Sterile Cast Padding
by Medi-Spec
510(k) K801554
Sterile Cast Padding is a Class I device made by Medi-Spec, cleared under FDA 510(k) K801554 on 4 Aug 1980, 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 | NumberK801554 | Date4 Aug 1980 | StatusActive |
Official records
- FDA 510(k) database K801554
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HIX
- Device class
- Class I
- Regulation
- 21 CFR Part 886.1435
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent