HRH · Trephine, Manual, Ophthalmic
Ophthalmic · 21 CFR 886.4350 · Class 1
Overview
| Product Code | HRH |
|---|---|
| Device Name | Trephine, Manual, Ophthalmic |
| Regulation | 21 CFR 886.4350 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Cleared Devices (12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022843 | GAYHEART CORNEAL EXCISION DEVICE | Stephens Instruments | Nov 1, 2002 | SESE |
| K931792 | ARTHROSCOPE | Intramed Laboratories, Inc. | Jun 13, 1994 | SESE |
| K873918 | HEAD & CHIN RESTS | Richmond Products, Inc. | Oct 28, 1987 | SESE |
| K864520 | BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON | Precision Instruments, Inc. | Jan 20, 1987 | SESE |
| K862524 | DEKNATEL (R) TREPHINE | Deknatel, Inc. | Aug 11, 1986 | SESE |
| K861825 | CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE | Storz Instrument Co. | Jun 9, 1986 | SESE |
| K860648 | BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA | Precision Instruments, Inc. | Mar 25, 1986 | SN |
| K843646 | STEINWAY MICRO-KERATO-TREPHINE | Steinway Instrument Co., Inc. | Jan 3, 1985 | SESE |
| K843048 | RING SUPPORTED TREPHINE FOR CORNEA TRANS | Precision Instruments, Inc. | Oct 5, 1984 | SESE |
| K812723 | PEARCE CORNEAL TREPHINE | Visitec Co. | Oct 13, 1981 | SESE |
| K781411 | CORNEAL CUTTER AND ACCESSORIES | Codman & Shurtleff, Inc. | Sep 20, 1978 | SESE |
| K771866 | TROUTMAN CORNEAL PUNCH | Edward Weck, Inc. | Nov 9, 1977 | SESE |
Top Applicants
- Precision Instruments, Inc. — 3 clearances
- Visitec Co. — 1 clearance
- Storz Instrument Co. — 1 clearance
- Stephens Instruments — 1 clearance
- Steinway Instrument Co., Inc. — 1 clearance
