Expandacell Eye Spear, Eye Wick, Wick Drain and Corneal Shield
by Shippert Medical Technologies Corp.
510(k) K964855
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964855 | Date4 Mar 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4790
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent