HNY · Cystotome
Ophthalmic · 21 CFR 886.4350 · Class 1
Overview
| Product Code | HNY |
|---|---|
| Device Name | Cystotome |
| 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 (20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K961524 | STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS | Sterilab, Inc. | May 16, 1996 | SESE |
| K880345 | CYSTOTOMES/KNIFES | Myocure, Inc. | May 3, 1988 | SESE |
| K875001 | PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874997 | PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874993 | PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874983 | PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874976 | PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874975 | PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K873163 | VAN DELLEN IRRIGATING CYSTOTOME | Van Dellen, Ltd. | Sep 4, 1987 | SESE |
| K871365 | CAPSULECTOMER CYSTOTOME | Noetix, Inc. | Apr 16, 1987 | SESE |
| K870439 | LOOK IRRIGATING CYSTOTOMES | Look, Inc. | Feb 20, 1987 | SESE |
| K862709 | MECHANICAL CYSTITOME | Rudolph Beaver, Inc. | Aug 1, 1986 | SESE |
| K852934 | PRECISION - COSMET CAPSULE COUPEUR | Precision-Cosmet Co., Inc. | Aug 8, 1985 | SESE |
| K841101 | CLAYMAN-PAREL CAPSULE COUPEUR | Miami Eye Technology, Inc. | May 16, 1984 | SESE |
| K840475 | CYSTOTOME, 140-S | Cilco, Inc. | Apr 5, 1984 | SESE |
| K840660 | POSTERIOR CAPSULOTOMY CYSTITOME | Sharpoint, Inc. | Mar 16, 1984 | SESE |
| K840659 | ANTERIOR CAPSULECTOMY CYSTITOME | Sharpoint, Inc. | Mar 16, 1984 | SESE |
| K831916 | DISPOSABLE CYSTOTOME | CooperVision, Inc. | Jul 12, 1983 | SESE |
| K830040 | DISPOSABLE CYSTOTOME | Contemporary Surgical Systems, Inc. | Feb 7, 1983 | SESE |
| K790244 | CYSTOTOMES | Visitec Co. | Feb 12, 1979 | SESE |
Top Applicants
- Advanced Surgical Products, Inc. — 6 clearances
- Sharpoint, Inc. — 2 clearances
- Visitec Co. — 1 clearance
- Van Dellen, Ltd. — 1 clearance
- Sterilab, Inc. — 1 clearance
