510(k) K913765
- Device
- Yasargil Aneurysm Clips, Modification
- Applicant
- AESCULAP, INC.
- 510(k) number
- K913765
- Product code
- HCH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-11
- Date received
- 1991-08-22
- Regulation
- 882.5200
- Classification name
- Clip, Aneurysm
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- VICTORIA MACKINNON
- Address
- 1000 Gateway Blvd. South San Francisco CA US 94080 94080
FDA Registration Numbers
- 3009217531
- 8030607
- 2916714
- 8010298
- 3010041511
- 8010890
- 3008770252
- 9610612
- 3011137372
- 3011547624
- 9680242
- 8010099
- 1836161
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Other 510(k) Records For Product Code HCH
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211183 | Sugita AVM Microclips | Mizuho America, Inc. | 2022-03-02 |
| K180757 | D-Clip; D-Clip Applier | Peter Lazic GmbH | 2019-04-12 |
| K131500 | YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS | Aesculap, Inc. | 2014-01-24 |
| K091921 | CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP | Codman & Shurtleff, Inc. | 2009-09-08 |
| K081640 | GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS | Gimmi GmbH | 2009-05-06 |
| K081489 | L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS | Peter Lazic GmbH | 2008-09-25 |
| K060915 | KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS | Kirwan Surgical Products, Inc. | 2007-04-17 |
| K043041 | AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) | Aesculap, Inc. | 2004-12-09 |
| K032198 | AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP | Aesculap, Inc. | 2003-08-20 |
| K031468 | TEMPORARY TITANIUM ANEURYSM CLIP | Cardinalhealth | 2003-06-20 |
| K024349 | AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER | Aesculap, Inc. | 2003-03-24 |
| K013136 | ANEURYSM CLIPS | Gistlstrasse | 2001-11-26 |
| K010908 | MEDICON TITANIUM YASARGIL ANEURYSM CLIPS | Medicon EG | 2001-08-01 |
| K003500 | REBSTOCK YASARGIL ANEURYSM CLIP | Rebstock - Instrumente GmbH | 2001-05-30 |
| K003519 | YASARGIL PERMANENT ANEURYSM CLIPS | Aesculap, Inc. | 2001-01-29 |