Product Code: HMX FDA class 1 21 CFR 886.4350

Cannula, Ophthalmic

Ophthalmic

The Ophthalmic Cannula is a thin, hollow tube used in ocular surgery to irrigate, aspirate, or inject fluids into anterior or posterior ocular structures during procedures such as cataract extraction or vitreoretinal surgery. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without a premarket notification requirement. The product code is HMX, regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty. No special risk flags apply to this device.

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510(k)s

FEI Numbers

234

Registration Numbers

235

Unique Applicants

Years Active

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Basic Information

Product Code: HMX
Device Class: FDA class 1
Regulation Number: 886.4350
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 77 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K010305	WEISS RETINAL CANNULA	May 02, 2001	Substantially Equivalent	Micron Surgical, Inc.
K000457	VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES	May 09, 2000	Substantially Equivalent	Retinalabs.Com
K970873	ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)	May 20, 1997	Substantially Equivalent	American Medical Devices, Inc.
K943932	STERISEAL OPHTHALMIC CANNULA	Jan 18, 1995	Substantially Equivalent	Pharma-Plast, Ltd.
K942403	INFUSION CANNULA	Aug 17, 1994	Substantially Equivalent	Microsurgical Technology, Inc.
K934844	INTER TIP T	Apr 19, 1994	Substantially Equivalent	Microsurgical Technology, Inc.
K930113	KIRWAN IRRIGATION/ASPIRATION HANDPIECE	Feb 17, 1994	Substantially Equivalent	Kirwan Surgical Products, Inc.
K921488	ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION	May 07, 1992	Substantially Equivalent	Surgical Technologies, Inc.
K915074	IRRIGATOR/ASPIRATOR PROBE	Feb 05, 1992	Substantially Equivalent	Biomedical Dynamics, Inc.
K904074	VITREORETINAL INFUSION CANNULA	Feb 26, 1991	Substantially Equivalent	Visitec Co.
K901618	OCULAR INFUSION CANNULA SYSTEM	May 31, 1990	Substantially Equivalent	Tamcenan Corp.
K890782	GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)	Jun 23, 1989	Substantially Equivalent	Grieshaber & Co.
K882884	STORZ INFUSION CANNULA	Aug 04, 1988	Substantially Equivalent	Storz Instrument Co.
K880347	ANESTHESIA/RETROBULBAR NEEDLES	May 03, 1988	Substantially Equivalent	Myocure, Inc.
K880346	CANNULAS	May 03, 1988	Substantially Equivalent	Myocure, Inc.
K875030	OCU-1	May 03, 1988	Substantially Equivalent	Rudolph Beaver, Inc.
K881487	OPHTHALMIC CANNULA	Apr 29, 1988	Substantially Equivalent	Surgical Instrument, Inc.
K875003	PRISMA DISPOSABLE PUPIL CENTERING CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K875002	PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874999	PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874998	PRISMA DISPOSABLE U-SHAPED CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874996	PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA.	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874995	PRISMA DISPOS. CURVED LACHRYMAL CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874994	PRISMA DISPOSABLE ANGLED I/A CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874992	PRISMA DISPOSABLE IRRIGATING LENS DIALER	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874990	PRISMA DISPOSABLE SILICONE BULB	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874989	PRISMA DISPOSABLE ADAPTER FOR IRRIGATORS	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874988	PRISMA DISPOS. PEARCE IRRIGATING VECTUS W/ONE PORT	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874987	PRISMA DISPOSABLE DOUBLE I/A CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874986	PRISMA DISPOSABLE RETROBULBAR NEEDLE	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874985	PRISMA DISPOSABLE CAPSULE POLISHER	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874984	PRISMA DISPOSABLE MICRO IRRIGATING VECTUS	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874982	PRISMA DISPOSABLE SIMCOE EXTRACTOR	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874981	PRISMA DISPOSABLE J-SHAPED I/A CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874980	PRISMA DISPOSABLE LEWICKY CHAMBER MAINTAINER	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874978	PRISMA DISPOSA. RYCROFT ANTERIOR CHAMBER CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874977	PRISMA DISPOSABLE DOUBLE I/A CANNULA CLOSED	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874974	PRISMA DISPOSABLE SIMCOE CAPSULE POLISHER	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874973	PRISMA DISPOSABLE SIMCOE I/A CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874972	PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874971	PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874970	PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874969	PRISMA DISPOSABLE KRATZ CAPSULE POLISHER	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874968	PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K873853	DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0	Mar 07, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K873164	VAN DELLEN HEALON CANNULA	Sep 04, 1987	Substantially Equivalent	Van Dellen, Ltd.
K873162	VAN DELLEN RETROBULBAR NEEDLE	Sep 04, 1987	Substantially Equivalent	Van Dellen, Ltd.
K872884	LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH	Aug 10, 1987	Substantially Equivalent	Look, Inc.
K872610	SOLOS EYESITE CANNULAS	Jul 31, 1987	Substantially Equivalent	Solos Ophthalmology
K872200	HAMACHER BULLET POINT OPHTHALMIC NEEDLE	Jun 25, 1987	Substantially Equivalent	R. J. Doyle, Inc.
K872151	OPHTHALMIC CANNULA	Jun 19, 1987	Substantially Equivalent	Pharmacia, Inc.
K871605	MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA	Jun 19, 1987	Substantially Equivalent	Advanced Surgical Products, Inc.
K870902	LOOK RETROBULBAR NEEDLES	Mar 20, 1987	Substantially Equivalent	Look, Inc.
K870441	LOOK CORTEX EXTRACTORS	Feb 20, 1987	Substantially Equivalent	Look, Inc.
K870438	LOOK IRRIGATING CANNULAS	Feb 20, 1987	Substantially Equivalent	Look, Inc.
K870436	LOOK IRRIGATING/ASPIRATING CANNULAS	Feb 20, 1987	Substantially Equivalent	Look, Inc.
K861545	IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES	May 28, 1986	Substantially Equivalent	Rophae Lens Co., Inc.
K860744	OPTHALMIC SURGICAL INSTRUMENTS	Mar 31, 1986	Substantially Equivalent	Tridak Division of Indicon, Inc.
K854506	STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA	Feb 07, 1986	Substantially Equivalent	Storz Instrument Co.
K854402	THE NEW MCINTYRE I.A. HANDPIECE	Dec 30, 1985	Substantially Equivalent	Microsurgical Technology, Inc.
K854401	THE NEW MOBILE TIP MCINTYRE CANNULA	Dec 30, 1985	Substantially Equivalent	Microsurgical Technology, Inc.
K853777	THE NEW MCINTYRE CANNULA	Nov 21, 1985	Substantially Equivalent	Microsurgical Technology, Inc.
K852758	INFUSION CANNULAM	Aug 01, 1985	Substantially Equivalent	Precision Medical Instruments, Inc.
K843039	SITE ANTERIOR CAPSULOTOMER	Nov 21, 1984	Substantially Equivalent	Chiron Vision Corp.
K840442	STERILIZED DISPOS. CYSTOTOME	Mar 16, 1984	Substantially Equivalent	Microsurgical Technology, Inc.
K831532	OCULAR IRRIGATING CANNULA	Jul 12, 1983	Substantially Equivalent	Dey Laboratories, Inc.
K831192	INFUSION CANNULA	Jun 30, 1983	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K813314	NLD IMPLANT SET	Feb 24, 1982	Substantially Equivalent	Design Research Assoc., Inc.
K813481	OMS INFUSION CANNULA ASSEMBLE	Jan 22, 1982	Substantially Equivalent	Optical Micro Systems, Inc.
K812010	KOI LACRIMAL INTUBATION SYSTEM	Jul 28, 1981	Substantially Equivalent	Koi, Inc.
K811455	ANIS GUIDING CANNULA	Jun 16, 1981	Substantially Equivalent	American V. Mueller
K801411	MAY ILLUMINATED/INFUSION PIC	Jul 21, 1980	Substantially Equivalent	Cooper Medical Devices Corp.
K791917	X-PAK	Oct 30, 1979	Substantially Equivalent	Contemporary Surgical Systems, Inc.
K791982	CANNULA'S CAT #'S 6636, 6624, 6625	Oct 04, 1979	Substantially Equivalent	Edward Weck, Inc.
K782169	NEEDLES, CANNULAS, CYSTOTOMES	Feb 13, 1979	Substantially Equivalent	Visitec Co.
K790243	CANNULAS	Feb 12, 1979	Substantially Equivalent	Visitec Co.
K771416	IRRIGATION/ASPIRATION NEEDLE	Sep 12, 1977	Substantially Equivalent	Concept, Inc.