SCALPFIX CLIP SYSTEM
FDA 510(k) clearance K012219 · decided 2001-07-31
Clearance details
- K-number
- K012219
- Device name
- SCALPFIX CLIP SYSTEM
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-16
- Decision date
- 2001-07-31
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- HBO
- Device class
- 2
- Regulation number
- 882.4150
- 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 |
|---|---|---|
| Raney Clips Kit (K253814) | Beijing Honghugaoxiang Science and Technology Development CO | 2026-07-21 |
| MEDTRONIC CLIP GUN KIT (K050044) | Medtronic Neurosurgery | 2005-02-07 |
| STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 (K033660) | Rudolf Storz GmbH | 2004-01-07 |
| ACRA-CUT (K944311) | Acra Cut, Inc. | 1994-11-18 |
| CODMAN DISPOSABLE SCALP CLIP APPLIER (K905433) | Codman & Shurtleff, Inc. | 1991-02-21 |
| CLIP GUN WITH RANEY TYPE SCALP CLIPS (K896723) | Omni Medical Designs | 1990-03-23 |
| CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER (K894778) | Codman & Shurtleff, Inc. | 1989-12-06 |
| CASPAR SCALP CLIP, APPLIER (K890443) | Aesculap Instruments Corp. | 1989-06-15 |
| RANEY AND LEROY-RANEY SCALP CLIP (K883963) | New England Surgical Instrument Corp. | 1988-10-07 |
| RANEY CLIPS (K881265) | Zimmer, Inc. | 1988-05-31 |
Recalls involving this device
No recalls on record reference this clearance.