Product code HRH
- Device name
- Trephine, Manual, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4350
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022843 | GAYHEART CORNEAL EXCISION DEVICE | Stephens Instruments | 2002-11-01 |
| K931792 | ARTHROSCOPE | Intramed Laboratories, Inc. | 1994-06-13 |
| K873918 | HEAD & CHIN RESTS | Richmond Products, Inc. | 1987-10-28 |
| K864520 | BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON | Precision Instruments, Inc. | 1987-01-20 |
| K862524 | DEKNATEL (R) TREPHINE | Deknatel, Inc. | 1986-08-11 |
| K861825 | CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE | Storz Instrument Co. | 1986-06-09 |
| K860648 | BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA | Precision Instruments, Inc. | 1986-03-25 |
| K843646 | STEINWAY MICRO-KERATO-TREPHINE | Steinway Instrument Co., Inc. | 1985-01-03 |
| K843048 | RING SUPPORTED TREPHINE FOR CORNEA TRANS | Precision Instruments, Inc. | 1984-10-05 |
| K812723 | PEARCE CORNEAL TREPHINE | Visitec Co. | 1981-10-13 |
| K781411 | CORNEAL CUTTER AND ACCESSORIES | Codman & Shurtleff, Inc. | 1978-09-20 |
| K771866 | TROUTMAN CORNEAL PUNCH | Edward Weck, Inc. | 1977-11-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810158217645 | PRINCETON | Princeton Medical Group, Inc. | 2025-10-17 |
| G412PH62110 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62250 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62240 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62230 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62220 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62200 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62190 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62180 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62170 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62210 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62100 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| 03700483602544 | ONE | MORIA SA | 2023-12-29 |
| 03700483602438 | ONE | MORIA SA | 2023-12-29 |
| 03700483602162 | ONE | MORIA SA | 2023-12-29 |
| 30886158101339 | Visitec® | Beaver-Visitec International, Inc. | 2021-11-01 |
| 00192896105485 | Corneal Trephine Blade | SONTEC INSTRUMENTS, INC. | 2020-11-16 |
| 00840159907863 | Rumex | RUMEX INTERNATIONAL CORP. | 2020-06-11 |
| 00840159907870 | Rumex | RUMEX INTERNATIONAL CORP. | 2020-06-11 |
| 00840159907986 | Rumex | RUMEX INTERNATIONAL CORP. | 2020-06-11 |
| 00840159907993 | Rumex | RUMEX INTERNATIONAL CORP. | 2020-06-11 |
| 00840159908006 | Rumex | RUMEX INTERNATIONAL CORP. | 2020-06-11 |
| 00840159908013 | Rumex | RUMEX INTERNATIONAL CORP. | 2020-06-11 |
| 00840159910054 | Rumex | RUMEX INTERNATIONAL CORP. | 2020-06-11 |
| 00840159910061 | Rumex | RUMEX INTERNATIONAL CORP. | 2020-06-11 |
| 00840159910078 | Rumex | RUMEX INTERNATIONAL CORP. | 2020-06-11 |
| 00840159910085 | Rumex | RUMEX INTERNATIONAL CORP. | 2020-06-11 |
| 00840159910092 | Rumex | RUMEX INTERNATIONAL CORP. | 2020-06-11 |
| 10381780404750 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-05-03 |
| 10381780362722 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |