HNC · Specula, Ophthalmic
Ophthalmic · 21 CFR 886.4350 · Class 1
Overview
| Product Code | HNC |
|---|---|
| Device Name | Specula, 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.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022836 | STEPHENS DISPOSABLE SPECULUM | Stephens Instruments | Nov 1, 2002 | SESE |
| K981235 | OCULOSTAT | Laser Center Dev. Corp. | Jul 15, 1998 | SESE |
| K964289 | EYE FIXATION SPECULUM | Eyefix, Inc. | Dec 17, 1996 | SESE |
| K863989 | THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) | Keeler Instruments, Inc. | Oct 31, 1986 | SESE |
| K863664 | OPHTHALMIC SURGICAL SPECULUM | Myocure, Inc. | Sep 25, 1986 | SESE |
| K843196 | VISITEC EYE SPECULUM | Visitec Co. | Oct 5, 1984 | SESE |
| K830430 | EYELID SPECULUM | Douglas C. Mckee & Co. | Jun 10, 1983 | SESE |
| K801969 | ASNIS GUIDED SCREW SYSTEMS | Howmedica Corp. | Aug 27, 1980 | SESE |
| K760849 | FELDSTEIN BLEPHAROSTOMY CLIP SQUARE | V. Mueller O.V. Baxter Healthcare Corp. | Nov 2, 1976 | SESE |
| K760848 | FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU | V. Mueller O.V. Baxter Healthcare Corp. | Nov 2, 1976 | SESE |
| K760847 | FELDSTEIN BLEPHAROPLASTY CLIP SHARP P | V. Mueller O.V. Baxter Healthcare Corp. | Nov 2, 1976 | SESE |
Top Applicants
- V. Mueller O.V. Baxter Healthcare Corp. — 3 clearances
- Visitec Co. — 1 clearance
- Stephens Instruments — 1 clearance
- Myocure, Inc. — 1 clearance
- Laser Center Dev. Corp. — 1 clearance
