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20GA Bipolar Manipulator

Model PD100.12 · Peregrine Surgical, Llc · DI 00632307001048

MPA — Endoilluminator · Class II · 21 CFR 876.1500

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.

71420272019-05: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 2.5/device2023-03: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 8/device2024-07: 0 reports for this device; peer average 8/device2024-08: 0 reports for this device; peer average 13.5/device2024-09: 0 reports for this device; peer average 27/device2024-10: 0 reports for this device; peer average 16/device2024-11: 0 reports for this device; peer average 6/device2024-12: 0 reports for this device; peer average 12/device2025-02: 0 reports for this device; peer average 4/device2025-03: 0 reports for this device; peer average 4/device2025-05: 0 reports for this device; peer average 2.5/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1.33/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 5/device2026-06: 0 reports for this device; peer average 1.5/device05120306100406070809101112020305060711010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0501
2022-1202.5
2023-0301
2023-0602
2023-1001
2024-0402
2024-0608
2024-0708
2024-08013.5
2024-09027
2024-10016
2024-1106
2024-12012
2025-0204
2025-0304
2025-0502.5
2025-0602
2025-0701.5
2025-1101
2026-0101.33
2026-0202
2026-0303
2026-0402
2026-0505
2026-0601.5
This device (reports/month)Average device in MPA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Peregrine Surgical, Llc

  • Warning Letter 2010-12-20 Peregrine Surgical Ltd
  • Warning Letter 2010-12-20 Peregrine Surgical Ltd
  • NAI 2018-09-26 Peregrine Surgical Ltd · 0 citations
  • NAI 2018-09-26 Peregrine Surgical Ltd · 0 citations
  • VAI 2015-06-19 Peregrine Surgical Ltd · 0 citations
  • VAI 2015-06-19 Peregrine Surgical Ltd · 0 citations
  • VAI 2013-02-07 Peregrine Surgical Ltd · 1 citations
  • VAI 2013-02-07 Peregrine Surgical Ltd · 1 citations
  • VAI 2011-06-30 Peregrine Surgical Ltd · 0 citations
  • VAI 2011-06-30 Peregrine Surgical Ltd · 0 citations
  • OAI 2010-07-15 Peregrine Surgical Ltd · 6 citations
  • OAI 2010-07-15 Peregrine Surgical Ltd · 6 citations