FDA 510(k)

KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES

K-Number: K062659 · 2007-03-09

Decision Date2007-03-09

Product CodeHQP

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES 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 2007-03-09 under 510(k) number K062659. The device is classified under product code HQP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES?

KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES is a medical device that received FDA 510(k) clearance on 2007-03-09. The listed applicant is Kirwan Surgical Products, Inc.. The 510(k) number is K062659.

When did KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES receive FDA 510(k) clearance?

KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES received FDA 510(k) clearance on 2007-03-09, under 510(k) number K062659.

Who is the listed applicant for KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES?

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 DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES?

The FDA product code for KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES is HQP.

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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 K052203AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 K023482AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 K992218DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601

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Related Devices (Code: HQP)

K121441CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)Bovie Medical Corporation K083428F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERYFiab Spa K023506SURGICAL MEDICAL DEVICE CAUTERYModern Medical Equipment Mfg., Ltd.K002547STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTORStarion Instruments K994019CAUTERY GRASPER/DISSECTORStarion Instruments K990728THERMAL CAUTERY DEVICE, FORCEPSStarion Instruments

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.