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510(k) K060915

KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS by Kirwan Surgical Products, Inc. — Product Code HCH

K060915 is an FDA 510(k) premarket notification submitted by Kirwan Surgical Products, Inc. for the device "KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS". The FDA issued a decision of Substantially Equivalent on April 17, 2007. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Kirwan Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2007
Date Received
April 4, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Aneurysm
Device Class
Class II
Regulation Number
882.5200
Review Panel
NE
Submission Type

Other clearances by Kirwan Surgical Products, Inc.

  • K231872 — Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module ( (August 25, 2023)
  • K100912 — DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULA (August 19, 2010)
  • K070360 — KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-36 (August 7, 2007)
  • K062659 — KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES (March 9, 2007)
  • K052203 — AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 (October 20, 2005)
  • K023482 — AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 (January 15, 2003)
  • K992218 — DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-46 (July 30, 1999)
  • K982176 — KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR (September 18, 1998)
  • K971341 — KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR (May 22, 1997)
  • K965241 — BIPOLAR SUCTION COAGULATOR (February 28, 1997)

Other clearances for product code HCH

  • K211183 — Sugita AVM Microclips (March 2, 2022)
  • K180757 — D-Clip; D-Clip Applier (April 12, 2019)
  • K131500 — YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS (January 24, 2014)
  • K091921 — CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REI (September 8, 2009)
  • K081640 — GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS (May 6, 2009)
  • K081489 — L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YAS (September 25, 2008)
  • K043041 — AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) (December 9, 2004)
  • K032198 — AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP (August 20, 2003)
  • K031468 — TEMPORARY TITANIUM ANEURYSM CLIP (June 20, 2003)
  • K024349 — AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER (March 24, 2003)

FDA data resources