ALCON FOLDING FORCEPS
FDA 510(k) clearance K895434 · decided 1989-12-04
Clearance details
- K-number
- K895434
- Device name
- ALCON FOLDING FORCEPS
- Applicant
- Alcon Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1989-09-08
- Decision date
- 1989-12-04
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- HNR
- 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 FORCEPS (K022835) | Stephens Instruments | 2002-11-01 |
| SOFT LENS FOLDING BLOCK (K891487) | Western Medical Products, Inc. | 1989-08-15 |
| PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR (K893199) | Allergan Medical Optics | 1989-06-16 |
| MCDONALD FOLDING FORCEPS (K885230) | Alcon Laboratories | 1989-05-17 |
| BRADBURY INTRAOCULAR RETINAL KIT CAT #200 (K881049) | Microline Pentax, Inc. | 1988-09-12 |
| IOL IMPLANTATION FORCEPS (K883197) | D & D Surgical | 1988-08-22 |
| ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS (K880274) | Advanced Surgical Products, Inc. | 1988-02-05 |
| OPHTHALMIC SURGICAL INSTRUMENTS (K864183) | Techno Ophthalmics Intl. | 1986-11-28 |
| OPHTHALMIC KNIFE & FORCEPS (K864266) | Western Medical Products, Inc. | 1986-11-28 |
| FAULKNER FORCEPS (K864071) | Staar Surgical Co. | 1986-11-13 |
| THORNTON TITANIUM FORCEPS (VARIOUS TYPES) (K863992) | Keeler Instruments, Inc. | 1986-10-31 |
| PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS (K864003) | Allergan, Inc. | 1986-10-31 |
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 |