HNN · Knife, Ophthalmic
Ophthalmic · 21 CFR 886.4350 · Class 1
Overview
| Product Code | HNN |
|---|---|
| Device Name | Knife, 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 (20 of 54)
Showing 20 most recent of 54 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110166 | CLEARCUT S SAFETY KNIFE | Alcon Research, Ltd. | May 20, 2011 | SESE |
| K922378 | OPHTHALMIC KNIFE | Microptics Development Laboratory | Dec 10, 1992 | SESE |
| K882402 | RETRACTIVE INCISION MICROMETER (RIM) GUAGE | Optical Center | Aug 22, 1988 | SESE |
| K881669 | MVR/STILETTO BLADE 20GA. - P/N 1900 | Advanced Surgical Products, Inc. | May 13, 1988 | SESE |
| K874979 | PRISMA DISPOSABLE MVR/STILETTO BLADE | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874057 | OPHTHALMIC TIP & BLADE SCALPELS | Myocure, Inc. | Dec 23, 1987 | SESE |
| K874056 | OPHTHALMIC DISPOSABLE BLADES | Myocure, Inc. | Dec 22, 1987 | SESE |
| K873385 | OPHTHALMIC PHACO-BLADE | Myocure, Inc. | Sep 21, 1987 | SESE |
| K871285 | KNIFE, OPHTHALMIC | Trueline Instruments, Inc. | Apr 27, 1987 | SESE |
| K864290 | RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE | Keeler Instruments, Inc. | Dec 15, 1986 | SESE |
| K863725 | CATARACT DIAMOND KNIFE | Medical Technology Development Corp. | Oct 31, 1986 | SESE |
| K863665 | THE ULTIMATE | Myocure, Inc. | Sep 25, 1986 | SESE |
| K861744 | SAPPHIRE KNIFE BLADE | Keeler Instruments, Inc. | Jun 9, 1986 | SESE |
| K861748 | RUBY & SAPPHIRE BLADE HOLDER | Keeler Instruments, Inc. | Jun 2, 1986 | SESE |
| K861732 | STORZ E9050 & E9055 DIAMOND KNIVES | Storz Instrument Co. | May 28, 1986 | SESE |
| K861491 | ROPHAE DIAMOND KNIFE | Rophae Lens Co., Inc. | May 28, 1986 | SESE |
| K861334 | CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE | Cilco, Inc. | May 2, 1986 | SESE |
| K860852 | SAPPHIRE BLADE SURGICAL KNIFE | Med-Tech Develoment Corp. | Mar 28, 1986 | SESE |
| K855050 | STORZ E9040 & E9046 DIAMOND KNIVES | Storz Instrument Co. | Mar 5, 1986 | SESE |
| K860332 | DIAMOND BLADE MICROMETER KNIFE | Med-Tech Develoment Corp. | Feb 13, 1986 | SESE |
Top Applicants
- Myocure, Inc. — 5 clearances
- Keeler Instruments, Inc. — 4 clearances
- V. Mueller O.V. Baxter Healthcare Corp. — 3 clearances
- Storz Instrument Co. — 3 clearances
- Sharpoint, Inc. — 3 clearances
