FDA 510(k)

KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS

K-Number: K060915 · 2007-04-17

Decision Date2007-04-17

Product CodeHCH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS 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 2007-04-17 under 510(k) number K060915. The device is classified under product code HCH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS?

KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS is a medical device that received FDA 510(k) clearance on 2007-04-17. The listed applicant is Kirwan Surgical Products, Inc.. The 510(k) number is K060915.

When did KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS receive FDA 510(k) clearance?

KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS received FDA 510(k) clearance on 2007-04-17, under 510(k) number K060915.

Who is the listed applicant for KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS?

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 L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS?

The FDA product code for KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS is HCH.

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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 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 K992218DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601

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Related Devices (Code: HCH)

K211183Sugita AVM MicroclipsMizuho America, Inc.K180757D-Clip; D-Clip ApplierPeter Lazic GmbH K091921CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIPCodman & Shurtleff, Inc.K081640GIMMI ANEURYSM CLIPS AND APPLYING FORCEPSGimmi GmbH K081489L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERSPeter Lazic GmbH K043041AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)Aesculap, Inc.

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.