Aesculap Slim Clip Applier
FDA 510(k) clearance K180914 · decided 2018-04-17
Clearance details
- K-number
- K180914
- Device name
- Aesculap Slim Clip Applier
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-04-09
- Decision date
- 2018-04-17
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- HCI
- Device class
- 2
- Regulation number
- 882.4175
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Center Valley, PA, US
- 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.
| Record | Firm | Date |
|---|---|---|
| Sugita AVM Microclip Applier (K221524) | Mizuho America, Inc. | 2022-06-24 |
| Aesculap Slim Clip Applier (K211572) | Aesculap, Inc. | 2021-12-13 |
| Aesculap Slim Clip Applier Forceps (K173271) | Aesculap, Inc. | 2017-11-10 |
| MEDICON YASARGIL CLIP APPLYING FORCEPS (K010910) | Medicon EG | 2001-08-01 |
| SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T (K994191) | Nmt Medical, Inc. | 2000-02-08 |
| AESCULAP AXIAL CLIP APPLIER (K984109) | Aesculap, Inc. | 1999-02-12 |
| SUNDT SLIM-LINE ANEURYSM CLIP APPLIER (K982379) | Johnson & Johnson Professionals, Inc. | 1998-12-18 |
| PERNECZKY CLIP APPLIER/REMOVER (K954658) | Von Zeppelin GmbH | 1996-10-08 |
| YASARGIL, CASPAR, VARIO CLIP APPLIERS (K940970) | Aesculap, Inc. | 1995-01-24 |
| SUNDT AVM MICRO CLIP (K902544) | Codman & Shurtleff, Inc. | 1990-09-20 |
| SANO CLIP APPLIERS & REMOVERS (K881912) | Downs Surgical , Ltd. | 1988-06-06 |
| NEW SIZES SUGITA CLIPS (K881911) | Downs Surgical , Ltd. | 1988-06-06 |
Recalls involving this device
No recalls on record reference this clearance.