Atlas FDA

ANEURYSM CLIPS

FDA 510(k) clearance K013136 · decided 2001-11-26

Clearance details

K-number
K013136
Device name
ANEURYSM CLIPS
Applicant
Gistlstrasse
Decision
Substantially Equivalent
Date received
2001-09-19
Decision date
2001-11-26
Days to decision
68 days
Clearance type
Traditional
Product code
HCH
Device class
2
Regulation number
882.5200
Medical specialty
Neurology
Advisory committee
Neurology
Location
Pullach, DE
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Sugita AVM Microclips (K211183)Mizuho America, Inc.2022-03-02
D-Clip; D-Clip Applier (K180757)Peter Lazic GmbH2019-04-12
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS (K131500)Aesculap, Inc.2014-01-24
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP (K091921)Codman & Shurtleff, Inc.2009-09-08
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS (K081640)Gimmi GmbH2009-05-06
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS (K081489)Peter Lazic GmbH2008-09-25
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS (K060915)Kirwan Surgical Products, Inc.2007-04-17
AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) (K043041)Aesculap, Inc.2004-12-09
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP (K032198)Aesculap, Inc.2003-08-20
TEMPORARY TITANIUM ANEURYSM CLIP (K031468)Cardinalhealth2003-06-20
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER (K024349)Aesculap, Inc.2003-03-24
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS (K010908)Medicon EG2001-08-01

Recalls involving this device

No recalls on record reference this clearance.