Trephine, Manual, Ophthalmic
FDA product code HRH · Class I (low risk) · 21 CFR 886.4350 · Ophthalmic
12510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022843 | Gayheart Corneal Excision DeviceHRH · Traditional | Stephens Instruments | 11/01/2002SE |
| K931792 | ArthroscopeHRH · Traditional | Intramed Laboratories, Inc. | 06/13/1994SE |
| K873918 | Head & Chin RestsHRH · Traditional | Richmond Products, Inc. | 10/28/1987SE |
| K864520 | Barron Rotary Blade Trephine Using Hessburg-BarronHRH · Traditional | Precision Instruments, Inc. | 01/20/1987SE |
| K862524 | Deknatel (R) TrephineHRH · Traditional | Deknatel, Inc. | 08/11/1986SE |
| K861825 | Corneal Transplant Trephine Disposable BladeHRH · Traditional | Storz Instrument Co. | 06/09/1986SE |
| K860648 | Barron Twin Blade Trephine for EppikaratophakiaHRH · Traditional | Precision Instruments, Inc. | 03/25/1986SN |
| K843646 | Steinway Micro-Kerato-TrephineHRH · Traditional | Steinway Instrument Co., Inc. | 01/03/1985SE |
| K843048 | Ring Supported Trephine for Cornea TransHRH · Traditional | Precision Instruments, Inc. | 10/05/1984SE |
| K812723 | Pearce Corneal TrephineHRH · Traditional | Visitec Co. | 10/13/1981SE |
| K781411 | Corneal Cutter and AccessoriesHRH · Traditional | Codman & Shurtleff, Inc. | 09/20/1978SE |
| K771866 | Troutman Corneal PunchHRH · Traditional | Edward Weck, Inc. | 11/09/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1632-2013 Class II | Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | Surgical Instrument Service And Savings, Inc. | 05/03/2013Terminated |