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AVANOS

Model 46932 · Avanos Medical, Inc. · DI 00193493469321

GXI — Probe, Radiofrequency Lesion · Class II · 21 CFR 882.4725

UDILibrary device dossier · generated 2026-09-11 · 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 (2)

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.

Injury: 2

358102019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1.4/device2019-05: 0 reports for this device; peer average 2.63/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 4.33/device2019-08: 0 reports for this device; peer average 10.2/device2019-09: 0 reports for this device; peer average 1.33/device2019-10: 0 reports for this device; peer average 5.25/device2019-11: 0 reports for this device; peer average 8.67/device2019-12: 0 reports for this device; peer average 1.25/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 4/device2020-05: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1.5/device2020-08: 0 reports for this device; peer average 3/device2020-09: 0 reports for this device; peer average 1.8/device2020-10: 0 reports for this device; peer average 1.5/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 3.33/device2021-01: 1 reports for this device; peer average 1.33/device2021-02: 0 reports for this device; peer average 1.5/device2021-04: 0 reports for this device; peer average 3/device2021-05: 0 reports for this device; peer average 1.25/device2021-06: 0 reports for this device; peer average 1.43/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1.5/device2021-11: 0 reports for this device; peer average 3/device2022-01: 0 reports for this device; peer average 1.5/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 10/device2022-07: 0 reports for this device; peer average 1.5/device2022-09: 0 reports for this device; peer average 5.5/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 1.67/device2022-12: 0 reports for this device; peer average 1.6/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1.25/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 4/device2023-10: 0 reports for this device; peer average 1.8/device2023-11: 0 reports for this device; peer average 1.25/device2023-12: 1 reports for this device; peer average 1.5/device2024-01: 0 reports for this device; peer average 2.25/device2024-02: 0 reports for this device; peer average 1.67/device2024-03: 0 reports for this device; peer average 2.25/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 2.5/device2024-08: 0 reports for this device; peer average 4/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 2.25/device2024-12: 0 reports for this device; peer average 1.67/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 3.75/device2025-03: 0 reports for this device; peer average 5/device2025-04: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 3.5/device2025-07: 0 reports for this device; peer average 1.75/device2025-08: 0 reports for this device; peer average 4.4/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1.4/device2025-11: 0 reports for this device; peer average 3.33/device2025-12: 0 reports for this device; peer average 2.4/device2026-01: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 1.83/device2026-03: 0 reports for this device; peer average 1.89/device2026-04: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 1.56/device2026-06: 0 reports for this device; peer average 3.17/device010304050607080910111202030507080910111201020405060708091011010203040506070910111202030405060708091011120102030405060708091012010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0302
2019-0401.4
2019-0502.63
2019-0603
2019-0704.33
2019-08010.2
2019-0901.33
2019-1005.25
2019-1108.67
2019-1201.25
2020-0202
2020-0304
2020-0502
2020-0701.5
2020-0803
2020-0901.8
2020-1001.5
2020-1101
2020-1203.33
2021-0111.33
2021-0201.5
2021-0403
2021-0501.25
2021-0601.43
2021-0702
2021-0801
2021-0902
2021-1001.5
2021-1103
2022-0101.5
2022-0202
2022-0302
2022-0402
2022-0502
2022-06010
2022-0701.5
2022-0905.5
2022-1002
2022-1101.67
2022-1201.6
2023-0202
2023-0301.25
2023-0402
2023-0502
2023-0602
2023-0702
2023-0802
2023-0904
2023-1001.8
2023-1101.25
2023-1211.5
2024-0102.25
2024-0201.67
2024-0302.25
2024-0402
2024-0502
2024-0601
2024-0702.5
2024-0804
2024-0901.5
2024-1002.25
2024-1201.67
2025-0102
2025-0203.75
2025-0305
2025-0403
2025-0503
2025-0603.5
2025-0701.75
2025-0804.4
2025-0902
2025-1001.4
2025-1103.33
2025-1202.4
2026-0103
2026-0201.83
2026-0301.89
2026-0403
2026-0501.56
2026-0603.17
This device (reports/month)Average device in GXI (reports/device/month)

Regulatory clearances

  • K163236 SESE 2016-12-16 (k number procode)

Predicate lineage

K163236 — cites (transitively): K062937 (d1), K150371 (d1), K102566 (d2), K121773 (d2), K141586 (d2), K010202 (d3), K060799 (d3), K062946 (d3), K080771 (d3), K972846 (d3), K994344 (d3) — cited as predicate by K192491, K203066

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

Manufacturer compliance record — Avanos Medical, Inc.

  • Warning Letter 2013-04-10 Avanos Medical, Inc.
  • Warning Letter 2013-04-10 Avanos Medical, Inc.
  • Warning Letter 2008-12-22 Avanos Medical, Inc.
  • Warning Letter 2008-12-22 Avanos Medical, Inc.
  • VAI 2023-12-15 Avanos Medical, Inc. · 3 citations
  • VAI 2023-12-15 Avanos Medical, Inc. · 3 citations
  • VAI 2018-10-02 Avanos Medical, Inc. · 1 citations
  • VAI 2018-10-02 Avanos Medical, Inc. · 1 citations
  • VAI 2016-07-29 Avanos Medical, Inc. · 1 citations
  • VAI 2016-07-29 Avanos Medical, Inc. · 1 citations
  • NAI 2014-11-05 Avanos Medical, Inc. · 0 citations
  • NAI 2014-11-05 Avanos Medical, Inc. · 0 citations
  • VAI 2014-03-07 Avanos Medical, Inc. · 4 citations
  • VAI 2014-03-07 Avanos Medical, Inc. · 4 citations
  • NAI 2013-12-10 Avanos Medical, Inc. · 0 citations
  • NAI 2013-12-10 Avanos Medical, Inc. · 0 citations
  • OAI 2013-01-04 Avanos Medical, Inc. · 6 citations
  • OAI 2013-01-04 Avanos Medical, Inc. · 6 citations
  • OAI 2012-10-31 Avanos Medical, Inc. · 10 citations
  • OAI 2012-10-31 Avanos Medical, Inc. · 10 citations
  • VAI 2011-07-08 Avanos Medical, Inc. · 8 citations
  • VAI 2011-07-08 Avanos Medical, Inc. · 8 citations
  • OAI 2010-11-19 Avanos Medical, Inc. · 4 citations
  • OAI 2010-11-19 Avanos Medical, Inc. · 4 citations