STEPHENS DISPOSABLE SCISSORS
FDA 510(k) clearance K022840 · decided 2002-11-01
Clearance details
- K-number
- K022840
- Device name
- STEPHENS DISPOSABLE SCISSORS
- 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
- HNF
- 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 |
|---|---|---|
| INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. (K897093) | Microline Pentax, Inc. | 1990-04-04 |
| MANUAL OPHTHALMIC SURGICAL INSTRUMENTS (K873099) | Alcon Laboratories | 1987-09-04 |
| 13-550,13-560 WESCOTT SCOSSORS (EYE) (K851768) | Artiberia | 1985-06-20 |
| SURGICAL INSTRUMENTS REPRESENT. 4 CLASS (K822151) | Robert I. Chien & Assoc., Inc. | 1982-08-19 |
| LITTAUER SCISSORS 5 1/2 (K821290) | Conphar, Inc. | 1982-05-28 |
| IRIS SCISSORS STRAIGHT 4 1/2 (K821286) | Conphar, Inc. | 1982-05-28 |
| OPHTHALMIC SCISSORS (K811245) | Keeler Instruments, Inc. | 1981-07-31 |
| SCISSORS, STRABIMUS, 4 STRAIGHT (K770040) | J. Sklar Mfg. Co., Inc. | 1977-01-14 |
| SCISSORS, STRABISMUS, 4 CURVED (K770041) | J. Sklar Mfg. Co., Inc. | 1977-01-14 |
| SCISSORS, IRIS (K770019) | J. Sklar Mfg. Co., Inc. | 1977-01-12 |
| SCISSORS, MICRO IRIS STRAIGHT (K760185) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-08-04 |
| SURGICAL INSTRUMENTS, OPTHALMIC (K760326) | Depuy, Inc. | 1976-08-04 |
Recalls involving this device
No recalls on record reference this clearance.