FDA 510(k)

KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR

K-Number: K971341 · 1997-05-22

Decision Date1997-05-22

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Kirwan Surgical Products, Inc.. It received FDA 510(k) clearance on 1997-05-22 under 510(k) number K971341. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR?

KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR is a medical device that received FDA 510(k) clearance on 1997-05-22. The listed applicant is Kirwan Surgical Products, Inc.. The 510(k) number is K971341.

When did KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR receive FDA 510(k) clearance?

KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR received FDA 510(k) clearance on 1997-05-22, under 510(k) number K971341.

Who is the listed applicant for KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR?

The FDA 510(k) record lists Kirwan Surgical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR?

The FDA product code for KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR is GEI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kirwan Surgical Products, Inc. as applicant

K100912DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE K070360KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 K060915KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS K062659KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES K052203AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 K023482AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500

View all 18 devices →

Related Devices (Code: GEI)

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.