Craniocut
510(k) K022942
Craniocut is a medical device (FDA Class II; FDA product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered)) made by Aesculap, Inc., cleared under FDA 510(k) K022942 on 21 Oct 2002, active as of 22 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 | NumberK022942 | Date21 Oct 2002 | StatusActive |
Official records
- FDA 510(k) database K022942
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HBE
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4310
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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