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Aspen® Discrete Drain

Model 370022 · ASPEN SURGICAL PRODUCTS, INC. · DI 00840113206032

GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered · Class I · 21 CFR 878.4680

UDILibrary device dossier · generated 2026-09-14 · 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.

13462019-01: 0 reports for this device; peer average 2.14/device2019-02: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 2.33/device2019-04: 0 reports for this device; peer average 1.43/device2019-05: 0 reports for this device; peer average 1.67/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1.78/device2019-08: 0 reports for this device; peer average 1.33/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1.25/device2019-12: 0 reports for this device; peer average 5.33/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2.89/device2020-03: 0 reports for this device; peer average 1.8/device2020-04: 0 reports for this device; peer average 1.5/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 1.2/device2020-07: 0 reports for this device; peer average 4/device2020-08: 0 reports for this device; peer average 3.67/device2020-09: 0 reports for this device; peer average 2.8/device2020-10: 0 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 3.56/device2020-12: 0 reports for this device; peer average 2.83/device2021-01: 0 reports for this device; peer average 5.8/device2021-02: 0 reports for this device; peer average 4/device2021-03: 0 reports for this device; peer average 4.5/device2021-04: 0 reports for this device; peer average 2.5/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2.18/device2021-07: 0 reports for this device; peer average 2.4/device2021-08: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 2.75/device2021-10: 0 reports for this device; peer average 1.67/device2021-11: 0 reports for this device; peer average 2.25/device2021-12: 0 reports for this device; peer average 2.5/device2022-01: 0 reports for this device; peer average 4/device2022-02: 0 reports for this device; peer average 1.25/device2022-03: 0 reports for this device; peer average 1.25/device2022-04: 0 reports for this device; peer average 2.5/device2022-05: 0 reports for this device; peer average 1.29/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1.5/device2022-08: 0 reports for this device; peer average 1.67/device2022-09: 0 reports for this device; peer average 1.75/device2022-10: 0 reports for this device; peer average 2.33/device2022-11: 0 reports for this device; peer average 1.75/device2022-12: 0 reports for this device; peer average 1.67/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.25/device2023-04: 0 reports for this device; peer average 1.5/device2023-05: 0 reports for this device; peer average 5/device2023-06: 0 reports for this device; peer average 1.67/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1.5/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1.5/device2023-11: 0 reports for this device; peer average 1.67/device2023-12: 0 reports for this device; peer average 1.67/device2024-01: 0 reports for this device; peer average 1.33/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 1.67/device2024-07: 0 reports for this device; peer average 3/device2024-08: 0 reports for this device; peer average 4/device2024-09: 0 reports for this device; peer average 1.2/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 4/device2024-12: 0 reports for this device; peer average 1.67/device2025-01: 0 reports for this device; peer average 1.4/device2025-02: 0 reports for this device; peer average 3/device2025-03: 0 reports for this device; peer average 2.5/device2025-04: 0 reports for this device; peer average 2.6/device2025-05: 0 reports for this device; peer average 1.44/device2025-06: 0 reports for this device; peer average 3.8/device2025-07: 0 reports for this device; peer average 3.6/device2025-08: 0 reports for this device; peer average 1.86/device2025-09: 0 reports for this device; peer average 2.29/device2025-10: 0 reports for this device; peer average 1.43/device2025-11: 0 reports for this device; peer average 2.6/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 4/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 1.6/device2026-04: 0 reports for this device; peer average 1.83/device2026-05: 0 reports for this device; peer average 2.75/device2026-06: 0 reports for this device; peer average 2.5/device0102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.14
2019-0203
2019-0302.33
2019-0401.43
2019-0501.67
2019-0601
2019-0701.78
2019-0801.33
2019-0902
2019-1001
2019-1101.25
2019-1205.33
2020-0102
2020-0202.89
2020-0301.8
2020-0401.5
2020-0502
2020-0601.2
2020-0704
2020-0803.67
2020-0902.8
2020-1002
2020-1103.56
2020-1202.83
2021-0105.8
2021-0204
2021-0304.5
2021-0402.5
2021-0502
2021-0602.18
2021-0702.4
2021-0803
2021-0902.75
2021-1001.67
2021-1102.25
2021-1202.5
2022-0104
2022-0201.25
2022-0301.25
2022-0402.5
2022-0501.29
2022-0602
2022-0701.5
2022-0801.67
2022-0901.75
2022-1002.33
2022-1101.75
2022-1201.67
2023-0101
2023-0201
2023-0301.25
2023-0401.5
2023-0505
2023-0601.67
2023-0701
2023-0801.5
2023-0902
2023-1001.5
2023-1101.67
2023-1201.67
2024-0101.33
2024-0201
2024-0302
2024-0501.5
2024-0601.67
2024-0703
2024-0804
2024-0901.2
2024-1002
2024-1104
2024-1201.67
2025-0101.4
2025-0203
2025-0302.5
2025-0402.6
2025-0501.44
2025-0603.8
2025-0703.6
2025-0801.86
2025-0902.29
2025-1001.43
2025-1102.6
2025-1202
2026-0104
2026-0202
2026-0301.6
2026-0401.83
2026-0502.75
2026-0602.5
This device (reports/month)Average device in GCY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ASPEN SURGICAL PRODUCTS, INC.

  • VAI 2017-11-08 Aspen Surgical Products, Inc. · 5 citations
  • VAI 2017-11-08 Aspen Surgical Products, Inc. · 5 citations
  • NAI 2017-03-02 Aspen Surgical Products Inc · 0 citations
  • NAI 2015-11-03 Aspen Surgical Puerto Rico Corp. · 0 citations
  • NAI 2015-02-11 Aspen Surgical Products, Inc. · 0 citations
  • NAI 2015-02-11 Aspen Surgical Products, Inc. · 0 citations
  • NAI 2014-07-01 Aspen Surgical Products Inc · 0 citations
  • VAI 2013-02-15 Aspen Surgical Products, Inc. · 1 citations
  • VAI 2013-02-15 Aspen Surgical Products, Inc. · 1 citations
  • NAI 2012-09-28 Aspen Surgical Products Inc · 0 citations
  • VAI 2010-02-26 Aspen Surgical Products, Inc. · 4 citations
  • VAI 2010-02-26 Aspen Surgical Products, Inc. · 4 citations