Trephine, Manual, Ophthalmic
A Manual Ophthalmic Trephine is a hand-operated surgical cutting instrument consisting of a cylindrical blade used to excise a circular disc of corneal or scleral tissue during corneal transplantation or other keratoplasty procedures, without requiring mechanical power. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification or approval. It carries product code HRH and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
Research product code HRH in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HRH
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K022843 | GAYHEART CORNEAL EXCISION DEVICE | Nov 01, 2002 | Substantially Equivalent | Stephens Instruments |
| K931792 | ARTHROSCOPE | Jun 13, 1994 | Substantially Equivalent | Intramed Laboratories, Inc. |
| K873918 | HEAD & CHIN RESTS | Oct 28, 1987 | Substantially Equivalent | Richmond Products, Inc. |
| K864520 | BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON | Jan 20, 1987 | Substantially Equivalent | Precision Instruments, Inc. |
| K862524 | DEKNATEL (R) TREPHINE | Aug 11, 1986 | Substantially Equivalent | Deknatel, Inc. |
| K861825 | CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE | Jun 09, 1986 | Substantially Equivalent | Storz Instrument Co. |
| K860648 | BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA | Mar 25, 1986 | Substantially Equivalent for Some Indications | Precision Instruments, Inc. |
| K843646 | STEINWAY MICRO-KERATO-TREPHINE | Jan 03, 1985 | Substantially Equivalent | Steinway Instrument Co., Inc. |
| K843048 | RING SUPPORTED TREPHINE FOR CORNEA TRANS | Oct 05, 1984 | Substantially Equivalent | Precision Instruments, Inc. |
| K812723 | PEARCE CORNEAL TREPHINE | Oct 13, 1981 | Substantially Equivalent | Visitec Co. |
| K781411 | CORNEAL CUTTER AND ACCESSORIES | Sep 20, 1978 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K771866 | TROUTMAN CORNEAL PUNCH | Nov 09, 1977 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 123 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 123 registration numbers. Click on an entry to view related FDA registrations.