ASCON SURGICAL INSTRUMENTS
FDA 510(k) clearance K852057 · decided 1985-06-27
Clearance details
- K-number
- K852057
- Device name
- ASCON SURGICAL INSTRUMENTS
- Applicant
- Ascon Medical Instruments, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-09
- Decision date
- 1985-06-27
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- HNR
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Westmont, IL, 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 |
|---|---|---|
| STEPHENS DISPOSABLE FORCEPS (K022835) | Stephens Instruments | 2002-11-01 |
| ALCON FOLDING FORCEPS (K895434) | Alcon Laboratories | 1989-12-04 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.