510(k) K881911
- Device
- NEW SIZES SUGITA CLIPS
- Applicant
- DOWNS SURGICAL LTD.
- 510(k) number
- K881911
- Product code
- HCI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-06-06
- Date received
- 1988-05-09
- Regulation
- 882.4175
- Classification name
- Applier, Aneurysm Clip
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN D FORSTER
- Address
- 42 Industrial Way Wilmington MA US 01887 01887
FDA Registration Numbers#
- 8010099
- 3005061536
- 8010298
- 9610612
- 9680242
- 8010890
- 2916714
- 1828464
- 3011547624
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HCI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221524 | Sugita AVM Microclip Applier | Mizuho America, Inc. | 2022-06-24 |
| K211572 | Aesculap Slim Clip Applier | Aesculap, Inc. | 2021-12-13 |
| K180914 | Aesculap Slim Clip Applier | Aesculap, Inc. | 2018-04-17 |
| K173271 | Aesculap Slim Clip Applier Forceps | Aesculap, Inc. | 2017-11-10 |
| K010910 | MEDICON YASARGIL CLIP APPLYING FORCEPS | Medicon EG | 2001-08-01 |
| K994191 | SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T | Nmt Medical, Inc. | 2000-02-08 |
| K984109 | AESCULAP AXIAL CLIP APPLIER | Aesculap, Inc. | 1999-02-12 |
| K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | Johnson & Johnson Professionals, Inc. | 1998-12-18 |
| K954658 | PERNECZKY CLIP APPLIER/REMOVER | Von Zeppelin GmbH | 1996-10-08 |
| K940970 | YASARGIL, CASPAR, VARIO CLIP APPLIERS | Aesculap, Inc. | 1995-01-24 |
| K902544 | SUNDT AVM MICRO CLIP | Codman & Shurtleff, Inc. | 1990-09-20 |
| K881912 | SANO CLIP APPLIERS & REMOVERS | Downs Surgical , Ltd. | 1988-06-06 |
| K833651 | CLIP APPLYING FORCEPS | Advanced Biosearch Assn. | 1983-11-29 |
Legacy Summary#
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FDA Review#
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