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2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal

Model PC-2.1E · Varian Medical Systems, Inc. · DI 00810563022032

GEH — Unit, Cryosurgical, Accessories · Class II · 21 CFR 878.4350

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

13452019-01: 0 reports for this device; peer average 4/device2019-02: 0 reports for this device; peer average 1.25/device2019-03: 0 reports for this device; peer average 1.8/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1.75/device2019-06: 0 reports for this device; peer average 1.5/device2019-07: 0 reports for this device; peer average 2.24/device2019-08: 0 reports for this device; peer average 1.89/device2019-09: 0 reports for this device; peer average 2.38/device2019-10: 0 reports for this device; peer average 2.46/device2019-11: 0 reports for this device; peer average 4.11/device2019-12: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 5/device2020-03: 0 reports for this device; peer average 2.85/device2020-04: 0 reports for this device; peer average 4.25/device2020-05: 0 reports for this device; peer average 2.5/device2020-06: 0 reports for this device; peer average 2.75/device2020-07: 0 reports for this device; peer average 2.38/device2020-08: 0 reports for this device; peer average 2.82/device2020-09: 0 reports for this device; peer average 3.14/device2020-10: 0 reports for this device; peer average 1.25/device2020-11: 0 reports for this device; peer average 5/device2020-12: 0 reports for this device; peer average 1.22/device2021-01: 0 reports for this device; peer average 1.8/device2021-02: 0 reports for this device; peer average 5/device2021-03: 0 reports for this device; peer average 2.38/device2021-04: 0 reports for this device; peer average 1.9/device2021-05: 0 reports for this device; peer average 2.13/device2021-06: 0 reports for this device; peer average 2.25/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 2.8/device2021-09: 0 reports for this device; peer average 1.86/device2021-10: 0 reports for this device; peer average 1.33/device2021-11: 0 reports for this device; peer average 3.33/device2021-12: 0 reports for this device; peer average 2.67/device2022-01: 0 reports for this device; peer average 2.36/device2022-02: 0 reports for this device; peer average 1.25/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1.77/device2022-05: 0 reports for this device; peer average 1.75/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 2.1/device2022-08: 0 reports for this device; peer average 3.57/device2022-09: 0 reports for this device; peer average 2.11/device2022-10: 0 reports for this device; peer average 2.1/device2022-11: 0 reports for this device; peer average 2.4/device2022-12: 0 reports for this device; peer average 1.43/device2023-01: 0 reports for this device; peer average 2.14/device2023-02: 0 reports for this device; peer average 1.3/device2023-03: 0 reports for this device; peer average 2.38/device2023-04: 0 reports for this device; peer average 1.7/device2023-05: 0 reports for this device; peer average 1.25/device2023-06: 0 reports for this device; peer average 1.29/device2023-07: 0 reports for this device; peer average 1.57/device2023-08: 0 reports for this device; peer average 3.2/device2023-09: 0 reports for this device; peer average 1.71/device2023-10: 0 reports for this device; peer average 1.45/device2023-11: 0 reports for this device; peer average 3/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1.25/device2024-02: 0 reports for this device; peer average 1.44/device2024-03: 0 reports for this device; peer average 1.43/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1.4/device2024-07: 0 reports for this device; peer average 1.4/device2024-08: 0 reports for this device; peer average 1.33/device2024-09: 0 reports for this device; peer average 1.67/device2024-10: 0 reports for this device; peer average 2.17/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2.5/device2025-01: 0 reports for this device; peer average 1.43/device2025-02: 0 reports for this device; peer average 1.33/device2025-03: 0 reports for this device; peer average 1.3/device2025-04: 0 reports for this device; peer average 1.86/device2025-05: 0 reports for this device; peer average 1.64/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 2.2/device2025-10: 0 reports for this device; peer average 1.33/device2025-11: 0 reports for this device; peer average 1.89/device2025-12: 0 reports for this device; peer average 3.17/device2026-01: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 3/device2026-03: 0 reports for this device; peer average 2.08/device2026-04: 0 reports for this device; peer average 2.57/device2026-05: 0 reports for this device; peer average 3.17/device2026-06: 0 reports for this device; peer average 2.71/device0102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104
2019-0201.25
2019-0301.8
2019-0402
2019-0501.75
2019-0601.5
2019-0702.24
2019-0801.89
2019-0902.38
2019-1002.46
2019-1104.11
2019-1203
2020-0103
2020-0205
2020-0302.85
2020-0404.25
2020-0502.5
2020-0602.75
2020-0702.38
2020-0802.82
2020-0903.14
2020-1001.25
2020-1105
2020-1201.22
2021-0101.8
2021-0205
2021-0302.38
2021-0401.9
2021-0502.13
2021-0602.25
2021-0702
2021-0802.8
2021-0901.86
2021-1001.33
2021-1103.33
2021-1202.67
2022-0102.36
2022-0201.25
2022-0302
2022-0401.77
2022-0501.75
2022-0602
2022-0702.1
2022-0803.57
2022-0902.11
2022-1002.1
2022-1102.4
2022-1201.43
2023-0102.14
2023-0201.3
2023-0302.38
2023-0401.7
2023-0501.25
2023-0601.29
2023-0701.57
2023-0803.2
2023-0901.71
2023-1001.45
2023-1103
2023-1201
2024-0101.25
2024-0201.44
2024-0301.43
2024-0401
2024-0501
2024-0601.4
2024-0701.4
2024-0801.33
2024-0901.67
2024-1002.17
2024-1102
2024-1202.5
2025-0101.43
2025-0201.33
2025-0301.3
2025-0401.86
2025-0501.64
2025-0702
2025-0801.67
2025-0902.2
2025-1001.33
2025-1101.89
2025-1203.17
2026-0103
2026-0203
2026-0302.08
2026-0402.57
2026-0503.17
2026-0602.71
This device (reports/month)Average device in GEH (reports/device/month)

Regulatory clearances

  • K230271 SESE 2023-03-28 (k number procode)

Predicate lineage

K230271 — cites (transitively): K011074 (d1), K060279 (d1), K101333 (d1), K141110 (d1), K151968 (d1), K153489 (d1), K201588 (d1), K003811 (d2), K111859 (d2), K140584 (d2), K143564 (d2), K963826 (d3), K121251 (d3), K113860 (d3), K123865 (d3), K060390 (d4) — cited as predicate by K243042

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Varian Medical Systems, Inc.

  • Warning Letter 2010-05-17 Varian Medical Systems, Inc.
  • Warning Letter 2010-05-17 Varian Medical Systems, Inc.
  • NAI 2023-09-20 Varian Medical Systems, Inc. · 0 citations
  • NAI 2023-09-20 Varian Medical Systems, Inc. · 0 citations
  • NAI 2022-09-07 Varian Medical Systems, Inc. · 0 citations
  • NAI 2017-09-01 Varian Medical Systems, Inc. · 0 citations
  • VAI 2017-07-20 VARIAN MEDICAL SYSTEMS HAAN GMBH · 2 citations
  • VAI 2017-01-12 Varian Medical Systems Imaging Laboratory GmbH · 1 citations
  • NAI 2016-12-15 Varian Medical Systems, Inc. · 0 citations
  • NAI 2016-12-15 Varian Medical Systems, Inc. · 0 citations
  • NAI 2016-08-31 Varian Medical Systems Inc · 0 citations
  • NAI 2016-08-10 Varian Medical Systems, Inc. · 0 citations
  • NAI 2016-08-10 Varian Medical Systems, Inc. · 0 citations
  • NAI 2016-01-15 Varian Medical Systems, Inc. · 0 citations
  • NAI 2016-01-15 Varian Medical Systems, Inc. · 0 citations
  • NAI 2015-07-10 Varian Medical Systems, Inc. · 0 citations
  • NAI 2015-07-10 Varian Medical Systems, Inc. · 0 citations
  • VAI 2015-05-20 Varian Medical Systems, Inc. · 2 citations
  • VAI 2015-05-20 Varian Medical Systems, Inc. · 2 citations
  • NAI 2014-06-06 Varian Medical Systems, Inc. · 0 citations
  • NAI 2014-06-06 Varian Medical Systems, Inc. · 0 citations
  • NAI 2014-06-02 Varian Medical Systems Inc · 0 citations