STEPHENS DISPOSABLE HOOKS
FDA 510(k) clearance K022842 · decided 2002-11-01
Clearance details
- K-number
- K022842
- Device name
- STEPHENS DISPOSABLE HOOKS
- Applicant
- Stephens Instruments
- Decision
- Substantially Equivalent
- Date received
- 2002-08-27
- Decision date
- 2002-11-01
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- HNQ
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Lexington, KY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OPHTEC ENCLAVATION NEEDLE (K030471) | Ophtec, USA | 2003-04-17 |
| PRISMA DISPOSABLE IRRIGATING IRIS HOOK (K874991) | Advanced Surgical Products, Inc. | 1988-04-13 |
| LOOK LENS LOOPS (K870440) | Look, Inc. | 1987-02-20 |
| DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY (K864292) | Eye-Ko, Inc. | 1986-12-29 |
| THORTON TITANIUM HOOK ANGLED RIGHT (K863988) | Keeler Instruments, Inc. | 1986-10-31 |
| BONN MICRO IRIS HOOK (NON-STERILE) #7613 (K801469) | Edward Weck, Inc. | 1980-07-28 |
| HOOKS #'S 7600,7602,7603,7616 (K791985) | Edward Weck, Inc. | 1979-10-04 |
| HOOK, IRIS, SHEPARD U-SHAPED (K770103) | Edward Weck, Inc. | 1977-01-25 |
| HOOK, IRIS, HERSHMAN (K770098) | Edward Weck, Inc. | 1977-01-24 |
Recalls involving this device
No recalls on record reference this clearance.