Irrigation/Aspiration Cannulas, Various Sizes
by Rophae Lens Co., Inc. 510(k)
Active
510(k) K861545
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861545 | Date28 May 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HMX
- Device Class
- Class I
- Regulation
- 21 CFR Part 886.4350
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent