Scalpfix Clip System
510(k) K012219
Scalpfix Clip System is a Class II device made by Aesculap, Inc., cleared under FDA 510(k) K012219 on 31 Jul 2001, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012219 | Date31 Jul 2001 | StatusActive |
Official records
- FDA 510(k) database K012219
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HBO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4150
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code HBO (Clip, Scalp).
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- RANEY AND LEROY-RANEY SCALP CLIP by New England Surgical Instrument Corp.
- Medtronic Clip Gun Kit by Medtronic Neurosurgery