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.
Cleared Devices (77)
| 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 |
| K874998 | PRISMA DISPOSABLE U-SHAPED CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874996 | PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA. | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874995 | PRISMA DISPOS. CURVED LACHRYMAL CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874994 | PRISMA DISPOSABLE ANGLED I/A CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874992 | PRISMA DISPOSABLE IRRIGATING LENS DIALER | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874990 | PRISMA DISPOSABLE SILICONE BULB | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874989 | PRISMA DISPOSABLE ADAPTER FOR IRRIGATORS | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874988 | PRISMA DISPOS. PEARCE IRRIGATING VECTUS W/ONE PORT | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874987 | PRISMA DISPOSABLE DOUBLE I/A CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874986 | PRISMA DISPOSABLE RETROBULBAR NEEDLE | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874985 | PRISMA DISPOSABLE CAPSULE POLISHER | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874984 | PRISMA DISPOSABLE MICRO IRRIGATING VECTUS | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874982 | PRISMA DISPOSABLE SIMCOE EXTRACTOR | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874981 | PRISMA DISPOSABLE J-SHAPED I/A CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874980 | PRISMA DISPOSABLE LEWICKY CHAMBER MAINTAINER | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874978 | PRISMA DISPOSA. RYCROFT ANTERIOR CHAMBER CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874977 | PRISMA DISPOSABLE DOUBLE I/A CANNULA CLOSED | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874974 | PRISMA DISPOSABLE SIMCOE CAPSULE POLISHER | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874973 | PRISMA DISPOSABLE SIMCOE I/A CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874972 | PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874971 | PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874970 | PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874969 | PRISMA DISPOSABLE KRATZ CAPSULE POLISHER | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K874968 | PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA | Advanced Surgical Products, Inc. | Apr 13, 1988 | SESE |
| K873853 | DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0 | Advanced Surgical Products, Inc. | Mar 7, 1988 | SESE |
| K873164 | VAN DELLEN HEALON CANNULA | Van Dellen, Ltd. | Sep 4, 1987 | SESE |
| K873162 | VAN DELLEN RETROBULBAR NEEDLE | Van Dellen, Ltd. | Sep 4, 1987 | SESE |
| K872884 | LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH | Look, Inc. | Aug 10, 1987 | SESE |
| K872610 | SOLOS EYESITE CANNULAS | Solos Ophthalmology | Jul 31, 1987 | SESE |
| K872200 | HAMACHER BULLET POINT OPHTHALMIC NEEDLE | R. J. Doyle, Inc. | Jun 25, 1987 | SESE |
| K872151 | OPHTHALMIC CANNULA | Pharmacia, Inc. | Jun 19, 1987 | SESE |
| K871605 | MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA | Advanced Surgical Products, Inc. | Jun 19, 1987 | SESE |
| K870902 | LOOK RETROBULBAR NEEDLES | Look, Inc. | Mar 20, 1987 | SESE |
| K870441 | LOOK CORTEX EXTRACTORS | Look, Inc. | Feb 20, 1987 | SESE |
| K870438 | LOOK IRRIGATING CANNULAS | Look, Inc. | Feb 20, 1987 | SESE |
| K870436 | LOOK IRRIGATING/ASPIRATING CANNULAS | Look, Inc. | Feb 20, 1987 | SESE |
| K861545 | IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES | Rophae Lens Co., Inc. | May 28, 1986 | SESE |
| K860744 | OPTHALMIC SURGICAL INSTRUMENTS | Tridak Division of Indicon, Inc. | Mar 31, 1986 | SESE |
| K854506 | STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA | Storz Instrument Co. | Feb 7, 1986 | SESE |
| K854402 | THE NEW MCINTYRE I.A. HANDPIECE | Microsurgical Technology, Inc. | Dec 30, 1985 | SESE |
| K854401 | THE NEW MOBILE TIP MCINTYRE CANNULA | Microsurgical Technology, Inc. | Dec 30, 1985 | SESE |
| K853777 | THE NEW MCINTYRE CANNULA | Microsurgical Technology, Inc. | Nov 21, 1985 | SESE |
| K852758 | INFUSION CANNULAM | Precision Medical Instruments, Inc. | Aug 1, 1985 | SESE |
| K843039 | SITE ANTERIOR CAPSULOTOMER | Chiron Vision Corp. | Nov 21, 1984 | SESE |
| K840442 | STERILIZED DISPOS. CYSTOTOME | Microsurgical Technology, Inc. | Mar 16, 1984 | SESE |
| K831532 | OCULAR IRRIGATING CANNULA | Dey Laboratories, Inc. | Jul 12, 1983 | SESE |
| K831192 | INFUSION CANNULA | Medical Instrument Development Laboratories, Inc. | Jun 30, 1983 | SESE |
| K813314 | NLD IMPLANT SET | Design Research Assoc., Inc. | Feb 24, 1982 | SESE |
| K813481 | OMS INFUSION CANNULA ASSEMBLE | Optical Micro Systems, Inc. | Jan 22, 1982 | SESE |
| K812010 | KOI LACRIMAL INTUBATION SYSTEM | Koi, Inc. | Jul 28, 1981 | SESE |
| K811455 | ANIS GUIDING CANNULA | American V. Mueller | Jun 16, 1981 | SESE |
| K801411 | MAY ILLUMINATED/INFUSION PIC | Cooper Medical Devices Corp. | Jul 21, 1980 | SESE |
| K791917 | X-PAK | Contemporary Surgical Systems, Inc. | Oct 30, 1979 | SESE |
| K791982 | CANNULA'S CAT #'S 6636, 6624, 6625 | Edward Weck, Inc. | Oct 4, 1979 | SESE |
| K782169 | NEEDLES, CANNULAS, CYSTOTOMES | Visitec Co. | Feb 13, 1979 | SESE |
| K790243 | CANNULAS | Visitec Co. | Feb 12, 1979 | SESE |
| K771416 | IRRIGATION/ASPIRATION NEEDLE | Concept, Inc. | Sep 12, 1977 | SESE |
Top Applicants
- Advanced Surgical Products, Inc. — 29 clearances
- Microsurgical Technology, Inc. — 6 clearances
- Look, Inc. — 5 clearances
- Visitec Co. — 3 clearances
- Van Dellen, Ltd. — 2 clearances
