HMX · Cannula, Ophthalmic
Ophthalmic · 21 CFR 886.4350 · Class 1
Overview
| Product Code | HMX |
|---|---|
| Device Name | Cannula, 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 77)
Showing 20 most recent of 77 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K010305 | WEISS RETINAL CANNULA | Micron Surgical, Inc. | May 2, 2001 | SESE |
| K000457 | VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES | Retinalabs.Com | May 9, 2000 | SESE |
| K970873 | ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) | American Medical Devices, Inc. | May 20, 1997 | SESE |
| K943932 | STERISEAL OPHTHALMIC CANNULA | Pharma-Plast, Ltd. | Jan 18, 1995 | SESE |
| K942403 | INFUSION CANNULA | Microsurgical Technology, Inc. | Aug 17, 1994 | SESE |
| K934844 | INTER TIP T | Microsurgical Technology, Inc. | Apr 19, 1994 | SESE |
| K930113 | KIRWAN IRRIGATION/ASPIRATION HANDPIECE | Kirwan Surgical Products, Inc. | Feb 17, 1994 | SESE |
| K921488 | ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION | Surgical Technologies, Inc. | May 7, 1992 | SESE |
| K915074 | IRRIGATOR/ASPIRATOR PROBE | Biomedical Dynamics, Inc. | Feb 5, 1992 | SESE |
| K904074 | VITREORETINAL INFUSION CANNULA | Visitec Co. | Feb 26, 1991 | SESE |
| K901618 | OCULAR INFUSION CANNULA SYSTEM | Tamcenan Corp. | May 31, 1990 | SESE |
| K890782 | GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) | Grieshaber & Co. | Jun 23, 1989 | SESE |
| K882884 | STORZ INFUSION CANNULA | Storz Instrument Co. | Aug 4, 1988 | SESE |
| K880347 | ANESTHESIA/RETROBULBAR NEEDLES | Myocure, Inc. | May 3, 1988 | SESE |
| K880346 | CANNULAS | Myocure, Inc. | May 3, 1988 | SESE |
| K875030 | OCU-1 | Rudolph Beaver, Inc. | May 3, 1988 | SESE |
| K881487 | OPHTHALMIC CANNULA | Surgical Instrument, Inc. | Apr 29, 1988 | SESE |
| K875003 | PRISMA DISPOSABLE PUPIL CENTERING CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K875002 | PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874999 | PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
Top Applicants
- Advanced Surgical Products, Inc. — 29 clearances
- Microsurgical Technology, Inc. — 6 clearances
- Look, Inc. — 5 clearances
- Visitec Co. — 3 clearances
- Myocure, Inc. — 2 clearances
