Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219619

FEI Number

1219619

Entity Name

KIRWAN SURGICAL PRODUCTS, LLC.

City/State/Country

MARSHFIELD, MA, US

Establishment Address

180 Enterprise Dr, MARSHFIELD, MA 02050, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KIRWAN SURGICAL PRODUCTS LLC (Owner Number: 1219619)

Owner / Operator Contact Address

180 ENTERPRISE DR., P.O. BOX 427, Marshfield, MA 02050, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K962678

PMA Number

N/A

All Registered Proprietary Names

Microinfertility Forceps, Titanium Bipolar Suction Coagulator Chisel Osteotome Aura 20 Watt Bipolar Electrosurgical Coagulator, Model 26-2500 Disposable Irrigation Bipolar Cord Assembly Bipolar Reusable Forceps Disposable Endoscopic Cord Disposable Monopolar Cord Reusable Endoscopic Cord Reusable Monopolar Cord Monopolar Suction Coagulator Bipolar Reusable Cord Bipolar Disposable Cord Mallet Carotid Artery Clamp ;REAMING FORCESP ETRACT ORTHOPEDIC/NALEBUFF GLENOID PUNCHES AURA 70 WATT BIPOLAR ELE Wire Pass Drills Cranio Blades Bipolar Intraocular Probe Bipolar Pencil Handswitching Momopolar Pencil Monopolar Pencil Microsurgical Instrument Kirwan Disposable Battery-powered Cautery, Model 41-61XX series Disposable Bipolar Coagulating Forceps Monopolar Chuck Handle Kirwan Disposable Nerve Stimulating Probes, 41-34XX Series Reusable Bipolar Pencil Coagulator Disposable Bipolar Pencil Coagulator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	1992-12-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	1992-12-31
HCE	Clamp, Carotid Artery	Neurology	Class 2	882.5175	2007-12-06
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	1992-12-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1998-07-31
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	1992-12-31
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	Class 2	886.4115	2007-03-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2010-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06

Official Correspondent

Matthew Prario

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KIRWAN SURGICAL PRODUCTS LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219619. Last updated year: 2026. Please use registration number 1219619 when referencing this establishment in official correspondence.