MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
FDA 510(k) clearance K873099 · decided 1987-09-04
Clearance details
- K-number
- K873099
- Device name
- MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
- Applicant
- Alcon Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1987-08-07
- Decision date
- 1987-09-04
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- HNF
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alcon Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STEPHENS DISPOSABLE SCISSORS (K022840) | Stephens Instruments | 2002-11-01 |
| INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. (K897093) | Microline Pentax, Inc. | 1990-04-04 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System; DISCOVISC Ophthalmic Viscosurgical D (P840064/S091) | Alcon Laboratories | 2025-10-03 |
| VISCOAT Ophthalmic Viscosurgical Device, DISCOVISC Ophthalmic Viscosurgical Device (P840064/S090) | Alcon Laboratories | 2025-07-25 |
| DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088) | Alcon Laboratories | 2025-02-26 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086) | Alcon Laboratories | 2024-08-12 |
| PMMA Single-Piece Anterior Chamber IOL (P880087/S033) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071) | Alcon Laboratories | 2024-06-20 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical (P840064/S085) | Alcon Laboratories | 2024-06-17 |