510(k) Report

FDA applicant

Kirwan Surgical Products, Inc.

Marshfield, MA19 decisions1990–20230 recalls

FDA records 19 decisions for Kirwan Surgical Products, Inc. (Marshfield, MA) from 1990 to 2023: 19 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HCZ (Forceps, Surgical, Gynecological). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Kirwan Surgical Products, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Kirwan Surgical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 32010: 12023: 1
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kirwan Surgical Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kirwan Surgical Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories11decisions
  • HCZForceps, Surgical, Gynecological1decision
  • HCHClip, Aneurysm1decision
  • LFLInstrument, Ultrasonic Surgical1decision
  • HQPUnit, Cautery, Thermal, Battery-Powered1decision
  • GAANeedle, Aspiration And Injection, Disposable1decision

Also: EJF (1), GXZ (1), HMX (1).

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K960455Bipolar Suction CoagulatorKirwan Surgical Products, Inc. · 19964cite it
  • K052203Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600Kirwan Surgical Products, Inc. · 20052cite it
  • K965241Bipolar Suction CoagulatorKirwan Surgical Products, Inc. · 19972cite it
  • K962678Bipolar Pencil CoagulatorKirwan Surgical Products, Inc. · 19962cite it
  • K900533Disposable Bipolar Coagulating ForcepsKirwan Surgical Products, Inc. · 19901cites it
  • K913514Electrosurgical Unit CableKirwan Surgical Products, Inc. · 19911cites it

What has FDA decided for it lately?

  • K231872Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light…Kirwan Surgical Products, LLC · 2023
  • K100912Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator Probe, Bipolar Side by…Kirwan Surgical Products, Inc. · 2010
  • K070360Kirwan Disposable 23KHZ Manifold Tubing, 40-3600, & 36KHZ Manifold Tubing, 40-3601Kirwan Surgical Products, Inc. · 2007
  • K060915Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and AppliersKirwan Surgical Products, Inc. · 2007
  • K062659Kirwan Disposable Battery-Powered Cautery, Model 41-61XX SeriesKirwan Surgical Products, Inc. · 2007
  • K052203Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600Kirwan Surgical Products, Inc. · 2005
  • K023482Aura 20 Bipolar Electrosurgical Coagulator, Model 26-2500Kirwan Surgical Products, Inc. · 2003
  • K992218Disposable Irrigation Bipolar Cord Assembly for Malis System CMC-II, Model 10-4601Kirwan Surgical Products, Inc. · 1999

All 18 as Kirwan Surgical Products, Inc. →The one decision as Kirwan Surgical Products, LLC →