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WA22306D BIPOLAR LOOP 24FR - 30 DEGREE

Model AED-WA22306D · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · DI 00848657018982

FDC — Resectoscope, Working Element · Class II · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-15 · 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 (1)

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.

Malfunction: 1

24682019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 3/device2020-09: 0 reports for this device; peer average 3/device2020-10: 0 reports for this device; peer average 4/device2021-02: 0 reports for this device; peer average 3/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 3/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 2.33/device2023-10: 0 reports for this device; peer average 3/device2023-11: 0 reports for this device; peer average 3/device2024-02: 0 reports for this device; peer average 3/device2024-03: 1 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 3/device2024-07: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 8/device2024-12: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2.5/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2.67/device2025-06: 0 reports for this device; peer average 2.5/device2025-07: 0 reports for this device; peer average 4/device2025-08: 0 reports for this device; peer average 5/device2025-10: 0 reports for this device; peer average 4/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 3.33/device2026-04: 0 reports for this device; peer average 4.5/device2026-05: 0 reports for this device; peer average 4/device0102050609010709100203040604091202031011020305071012020405060708101201020405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0202
2019-0502
2019-0602
2019-0902
2020-0101
2020-0703
2020-0903
2020-1004
2021-0203
2021-0302
2021-0402
2021-0602
2022-0403
2022-0901
2022-1203
2023-0203
2023-0302.33
2023-1003
2023-1103
2024-0203
2024-0311
2024-0503
2024-0701
2024-1008
2024-1202
2025-0202.5
2025-0402
2025-0502.67
2025-0602.5
2025-0704
2025-0805
2025-1004
2025-1202
2026-0102
2026-0203.33
2026-0404.5
2026-0504
This device (reports/month)Average device in FDC (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