CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE
FDA 510(k) clearance K861825 · decided 1986-06-09
Clearance details
- K-number
- K861825
- Device name
- CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE
- Applicant
- Storz Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-12
- Decision date
- 1986-06-09
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- HRH
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St. Louis, MO, 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 |
|---|---|---|
| GAYHEART CORNEAL EXCISION DEVICE (K022843) | Stephens Instruments | 2002-11-01 |
| ARTHROSCOPE (K931792) | Intramed Laboratories, Inc. | 1994-06-13 |
| HEAD & CHIN RESTS (K873918) | Richmond Products, Inc. | 1987-10-28 |
| BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON (K864520) | Precision Instruments, Inc. | 1987-01-20 |
| DEKNATEL (R) TREPHINE (K862524) | Deknatel, Inc. | 1986-08-11 |
| BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA (K860648) | Precision Instruments, Inc. | 1986-03-25 |
| STEINWAY MICRO-KERATO-TREPHINE (K843646) | Steinway Instrument Co., Inc. | 1985-01-03 |
| RING SUPPORTED TREPHINE FOR CORNEA TRANS (K843048) | Precision Instruments, Inc. | 1984-10-05 |
| PEARCE CORNEAL TREPHINE (K812723) | Visitec Co. | 1981-10-13 |
| CORNEAL CUTTER AND ACCESSORIES (K781411) | Codman & Shurtleff, Inc. | 1978-09-20 |
| TROUTMAN CORNEAL PUNCH (K771866) | Edward Weck, Inc. | 1977-11-09 |
Recalls involving this device
No recalls on record reference this clearance.