# Kirwan Surgical Products, Inc.

- Location (FDA's records): Marshfield, MA
- FDA decisions: 19 (1990–2023): 19 510(k) clearances
- Names in FDA's records: Kirwan Surgical Products, Inc. (18); Kirwan Surgical Products, LLC (1)
- Product codes: GEI (11), HCZ (1), HCH (1), LFL (1), HQP (1), GAA (1), EJF (1), GXZ (1), HMX (1)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 14 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Technomed Europe: 1 (https://510kreport.com/company/technomed-europe)

## Firms that cite its devices most
- Omniguide, Inc.: 2 (https://510kreport.com/company/omniguide)
- Rebound Therapeutics: 2 (https://510kreport.com/company/rebound-therapeutics)
- Vnus Medical Technologies, Inc.: 1 (https://510kreport.com/company/vnus-medical-technologies)
- Hydrocision, Inc.: 1 (https://510kreport.com/company/hydrocision)
- Nico Corporation: 1 (https://510kreport.com/company/nico)
- Xomed, Inc.: 1 (https://510kreport.com/company/xomed)
- Ion Medical, LLC: 1 (https://510kreport.com/company/ion-medical)
- Ortho Development Corp.: 1 (https://510kreport.com/company/ortho-development)

## Its most-cited devices
- K960455: Bipolar Suction Coagulator (1996), cited by 4
- K052203: Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600 (2005), cited by 2
- K965241: Bipolar Suction Coagulator (1997), cited by 2
- K962678: Bipolar Pencil Coagulator (1996), cited by 2
- K900533: Disposable Bipolar Coagulating Forceps (1990), cited by 1
- K913514: Electrosurgical Unit Cable (1991), cited by 1

## Recent decisions
- K231872: Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) (Aug 25, 2023)
- K100912: Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator Probe, Bipolar Side by Side (Aug 19, 2010)
- K070360: Kirwan Disposable 23KHZ Manifold Tubing, 40-3600, & 36KHZ Manifold Tubing, 40-3601 (Aug 7, 2007)
- K060915: Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and Appliers (Apr 17, 2007)
- K062659: Kirwan Disposable Battery-Powered Cautery, Model 41-61XX Series (Mar 9, 2007)
- K052203: Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600 (Oct 20, 2005)
- K023482: Aura 20 Bipolar Electrosurgical Coagulator, Model 26-2500 (Jan 15, 2003)
- K992218: Disposable Irrigation Bipolar Cord Assembly for Malis System CMC-II, Model 10-4601 (Jul 30, 1999)

Source page: https://510kreport.com/company/kirwan-surgical-products