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AED

Model W1616 · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · DI 00848657009607

NWV — Laparoscopic Accessories, Gynecologic · Class I · 21 CFR 884.1720

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.

24682019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2.33/device2019-05: 0 reports for this device; peer average 1.33/device2019-07: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 3/device2020-03: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 8/device2020-08: 0 reports for this device; peer average 3/device2020-10: 0 reports for this device; peer average 4/device2020-11: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1.5/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 3/device2023-08: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 3/device2024-03: 0 reports for this device; peer average 2/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 2/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 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 6.5/device2025-02: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 3/device2026-03: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device0203040507101202030607081011030406070810111202050610120102030607081011030405060708091011120206070801030506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0202
2019-0302
2019-0402.33
2019-0501.33
2019-0702
2019-1002
2019-1201
2020-0203
2020-0302
2020-0603
2020-0708
2020-0803
2020-1004
2020-1102
2021-0303
2021-0402
2021-0602
2021-0701
2021-0802
2021-1002
2021-1101.5
2021-1202
2022-0201
2022-0503
2022-0601
2022-1001.5
2022-1201
2023-0102
2023-0203
2023-0303
2023-0601
2023-0703
2023-0802
2023-1001
2023-1103
2024-0302
2024-0402
2024-0502
2024-0602
2024-0701
2024-0802
2024-0902
2024-1002
2024-1104
2024-1206.5
2025-0202
2025-0602
2025-0702
2025-0803
2026-0103
2026-0303
2026-0502
2026-0602
This device (reports/month)Average device in NWV (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

  • VAI 2024-01-12 National Advanced Endoscopy Devices Inc · 0 citations
  • VAI 2024-01-12 National Advanced Endoscopy Devices Inc · 0 citations
  • VAI 2020-09-03 National Advanced Endoscopy Devices Inc · 1 citations
  • VAI 2020-09-03 National Advanced Endoscopy Devices Inc · 1 citations
  • VAI 2019-08-30 National Advanced Endoscopy Devices Inc · 1 citations
  • VAI 2019-08-30 National Advanced Endoscopy Devices Inc · 1 citations
  • VAI 2015-10-26 National Advanced Endoscopy Devices Inc · 3 citations
  • VAI 2015-10-26 National Advanced Endoscopy Devices Inc · 3 citations
  • NAI 2012-07-17 National Advanced Endoscopy Devices Inc · 0 citations
  • NAI 2012-07-17 National Advanced Endoscopy Devices Inc · 0 citations