Product Code: HNR FDA class 1 21 CFR 886.4350

Forceps, Ophthalmic

Ophthalmic

Ophthalmic Forceps are surgical grasping instruments used in eye surgery to handle, position, and manipulate delicate ocular tissues and structures, including the cornea, iris, lens capsule, sutures, and foreign bodies. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket notification or approval. It carries product code HNR and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

View on FDA

510(k)s

FEI Numbers

275

Registration Numbers

276

Unique Applicants

Years Active

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Basic Information

Product Code: HNR
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 44 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K022835	STEPHENS DISPOSABLE FORCEPS	Nov 01, 2002	Substantially Equivalent	Stephens Instruments
K895434	ALCON FOLDING FORCEPS	Dec 04, 1989	Substantially Equivalent	Alcon Laboratories
K891487	SOFT LENS FOLDING BLOCK	Aug 15, 1989	Substantially Equivalent	Western Medical Products, Inc.
K893199	PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR	Jun 16, 1989	Substantially Equivalent	Allergan Medical Optics
K885230	MCDONALD FOLDING FORCEPS	May 17, 1989	Substantially Equivalent	Alcon Laboratories
K881049	BRADBURY INTRAOCULAR RETINAL KIT CAT #200	Sep 12, 1988	Substantially Equivalent	Microline Pentax, Inc.
K883197	IOL IMPLANTATION FORCEPS	Aug 22, 1988	Substantially Equivalent	D & D Surgical
K880274	ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS	Feb 05, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K864266	OPHTHALMIC KNIFE & FORCEPS	Nov 28, 1986	Substantially Equivalent	Western Medical Products, Inc.
K864183	OPHTHALMIC SURGICAL INSTRUMENTS	Nov 28, 1986	Substantially Equivalent	Techno Ophthalmics Intl.
K864071	FAULKNER FORCEPS	Nov 13, 1986	Substantially Equivalent	Staar Surgical Co.
K864003	PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS	Oct 31, 1986	Substantially Equivalent	Allergan, Inc.
K863992	THORNTON TITANIUM FORCEPS (VARIOUS TYPES)	Oct 31, 1986	Substantially Equivalent	Keeler Instruments, Inc.
K863991	THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND	Oct 31, 1986	Substantially Equivalent	Keeler Instruments, Inc.
K863727	FIXATION INSTRUMENTS	Oct 31, 1986	Substantially Equivalent	Medical Technology Development Corp.
K861141	MANUAL OPHTHALMIC SURGICAL INSTRUMENTS	Apr 24, 1986	Substantially Equivalent	CooperVision, Inc.
K861057	MANUAL OPHTHALMIC SURGICAL INSTRUMENTS	Apr 24, 1986	Substantially Equivalent	Precision-Cosmet Co., Inc.
K860915	STORZ/MAZZACCO LENS FORCEP	Apr 15, 1986	Substantially Equivalent	Storz Instrument Co.
K854869	INTRAOCULAR FORCEPS & SCISSORS	Mar 05, 1986	Substantially Equivalent	Mira, Inc.
K852057	ASCON SURGICAL INSTRUMENTS	Jun 27, 1985	Substantially Equivalent	Ascon Medical Instruments, Ltd.
K851792	37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS	May 30, 1985	Substantially Equivalent	Artiberia
K851791	37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS	May 30, 1985	Substantially Equivalent	Artiberia
K850119	PHARMASEAL EYE PREP TRAY	May 09, 1985	Substantially Equivalent	American Pharmaseal Div. Ahsc
K844129	SHURE GRIP TYING FORCEPS	Nov 21, 1984	Substantially Equivalent	Mentor O & O, Inc.
K843992	CILCOR OPHTHALMIC INSTRUMENTS	Nov 21, 1984	Substantially Equivalent	Cilco, Inc.
K842697	ROOTMAN ORBITAL SURGERY INSTRUMENT SET	Aug 07, 1984	Substantially Equivalent	Downs Surgical , Ltd.
K834355	MICRO FORCEPS	Mar 16, 1984	Substantially Equivalent	Jedmed Instrument Co.
K823174	MICROSURGICAL INSTRUMENTS	Nov 16, 1982	Substantially Equivalent	Concept, Inc.
K811658	ANIS LENS IMPLANT FORCEPS #2	Jun 26, 1981	Substantially Equivalent	American V. Mueller
K803194	FISHER-PICKERING INTRAOCULAR EYE MAGNET	Feb 04, 1981	Substantially Equivalent	Storz Instrument Co.
K801467	DODICK LENS HOLDING FORCEPS	Jul 28, 1980	Substantially Equivalent	Edward Weck, Inc.
K801465	GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE	Jul 28, 1980	Substantially Equivalent	Edward Weck, Inc.
K800368	OPHTHALMIC FORCEPS	Mar 12, 1980	Substantially Equivalent	Edward Weck, Inc.
K791986	FIX. & LENS FOR. #'S 3510,3512,3248,3795	Oct 04, 1979	Substantially Equivalent	Edward Weck, Inc.
K771003	LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS	Jun 17, 1977	Substantially Equivalent	Edward Weck, Inc.
K770105	SHEPARD II, LENS FORCEP W/ LOCK	Jan 25, 1977	Substantially Equivalent	Edward Weck, Inc.
K770101	SHEPARD LENS FORCEP W/ IRRIGATOR & LOCK	Jan 25, 1977	Substantially Equivalent	Edward Weck, Inc.
K770104	BINKHORST LENS FORCEPS W/OUT IRRIGATOR	Jan 24, 1977	Substantially Equivalent	Edward Weck, Inc.
K770102	HERSHMAN LENS FORCEPS W/OUT IRRIGATOR	Jan 24, 1977	Substantially Equivalent	Edward Weck, Inc.
K770100	BINKHORST LENS FORCEP W/ IRRIGATOR	Jan 24, 1977	Substantially Equivalent	Edward Weck, Inc.
K770099	SHEPARD LENS FORCEP W/ IRRIGA W/OUT LOCK	Jan 24, 1977	Substantially Equivalent	Edward Weck, Inc.
K770097	HERSHMAN LENS FORCEPS WITH IRRIGATOR	Jan 24, 1977	Substantially Equivalent	Edward Weck, Inc.
K761252	WECK TYING FORCEP, CURVED TITANIUM	Dec 16, 1976	Substantially Equivalent	Edward Weck, Inc.
K761251	WECK TYING FORCEP, STRAIGHT TITANIUM	Dec 16, 1976	Substantially Equivalent	Edward Weck, Inc.