Product Code: HNN FDA class 1 21 CFR 886.4350

Knife, Ophthalmic

Ophthalmic

An Ophthalmic Knife is a surgical cutting instrument designed for precise incisions in ocular surgery, used to create controlled cuts in the cornea, sclera, or other eye structures during procedures such as cataract removal or refractive surgery. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket notification. It carries product code HNN and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

View on FDA

510(k)s

FEI Numbers

206

Registration Numbers

207

Unique Applicants

Years Active

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Basic Information

Product Code: HNN
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 54 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K110166	CLEARCUT S SAFETY KNIFE	May 20, 2011	Substantially Equivalent	Alcon Research, Ltd.
K922378	OPHTHALMIC KNIFE	Dec 10, 1992	Substantially Equivalent	Microptics Development Laboratory
K882402	RETRACTIVE INCISION MICROMETER (RIM) GUAGE	Aug 22, 1988	Substantially Equivalent	Optical Center
K881669	MVR/STILETTO BLADE 20GA. - P/N 1900	May 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874979	PRISMA DISPOSABLE MVR/STILETTO BLADE	Apr 13, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K874057	OPHTHALMIC TIP & BLADE SCALPELS	Dec 23, 1987	Substantially Equivalent	Myocure, Inc.
K874056	OPHTHALMIC DISPOSABLE BLADES	Dec 22, 1987	Substantially Equivalent	Myocure, Inc.
K873385	OPHTHALMIC PHACO-BLADE	Sep 21, 1987	Substantially Equivalent	Myocure, Inc.
K871285	KNIFE, OPHTHALMIC	Apr 27, 1987	Substantially Equivalent	Trueline Instruments, Inc.
K864290	RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE	Dec 15, 1986	Substantially Equivalent	Keeler Instruments, Inc.
K863725	CATARACT DIAMOND KNIFE	Oct 31, 1986	Substantially Equivalent	Medical Technology Development Corp.
K863665	THE ULTIMATE	Sep 25, 1986	Substantially Equivalent	Myocure, Inc.
K861744	SAPPHIRE KNIFE BLADE	Jun 09, 1986	Substantially Equivalent	Keeler Instruments, Inc.
K861748	RUBY & SAPPHIRE BLADE HOLDER	Jun 02, 1986	Substantially Equivalent	Keeler Instruments, Inc.
K861732	STORZ E9050 & E9055 DIAMOND KNIVES	May 28, 1986	Substantially Equivalent	Storz Instrument Co.
K861491	ROPHAE DIAMOND KNIFE	May 28, 1986	Substantially Equivalent	Rophae Lens Co., Inc.
K861334	CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE	May 02, 1986	Substantially Equivalent	Cilco, Inc.
K860852	SAPPHIRE BLADE SURGICAL KNIFE	Mar 28, 1986	Substantially Equivalent	Med-Tech Develoment Corp.
K855050	STORZ E9040 & E9046 DIAMOND KNIVES	Mar 05, 1986	Substantially Equivalent	Storz Instrument Co.
K860332	DIAMOND BLADE MICROMETER KNIFE	Feb 13, 1986	Substantially Equivalent	Med-Tech Develoment Corp.
K860331	DISPOSABLE SURGICAL KNIFE	Feb 12, 1986	Substantially Equivalent	Med-Tech Develoment Corp.
K860305	BEAVER MICRO-GEM GAUGE BLOCK	Feb 12, 1986	Substantially Equivalent	Rudolph Beaver, Inc.
K853598	OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE	Nov 04, 1985	Substantially Equivalent	Myocure, Inc.
K853403	STORZ DIAMOND KNIFE	Nov 04, 1985	Substantially Equivalent for Some Indications	Storz Instrument Co.
K853063	SMARTKNIFE SYSTEM	Nov 04, 1985	Substantially Equivalent for Some Indications	CooperVision, Inc.
K852828	BEAVER R-K KNIFE	Nov 04, 1985	Substantially Equivalent for Some Indications	Rudolph Beaver, Inc.
K852706	VERSABLADE	Nov 04, 1985	Substantially Equivalent for Some Indications	Alphamedix, Inc.
K852633	VERSABLADE	Nov 04, 1985	Substantially Equivalent for Some Indications	Alphamedix, Inc.
K853499	MICRON-SCOPE	Sep 24, 1985	Substantially Equivalent	Magnum Diamond, Inc.
K853129	BEAVER MULTIPURPOSE SAPPHIRE KNIFE	Aug 06, 1985	Substantially Equivalent	Rudolph Beaver, Inc.
K851790	37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN	May 23, 1985	Substantially Equivalent	Artiberia
K842647	CATARACT TRAY	May 09, 1985	Substantially Equivalent	Deroyal Industries, Inc.
K850049	KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA	Mar 06, 1985	Substantially Equivalent	Xtal Corp.
K844553	MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE	Dec 11, 1984	Substantially Equivalent	Codman & Shurtleff, Inc.
K843447	CILCO DIAMOND KNIFE	Oct 05, 1984	Substantially Equivalent	Cilco, Inc.
K841951	MICROSURGICAL KNIFE	Jun 01, 1984	Substantially Equivalent	ETHICON, Inc.
K840855	CORNEAL SCLERAL LANCE	May 09, 1984	Substantially Equivalent	Sharpoint, Inc.
K834546	SURGICAL KNIFE	Mar 16, 1984	Substantially Equivalent	Fine-Cut Diamond Instruments
K832844	RUBY KNIVES FOR OPHTH. SURGERY	Sep 29, 1983	Substantially Equivalent	Keeler Instruments, Inc.
K831975	LEADING EDGE OPHTHALMIC KNIFE	Aug 31, 1983	Substantially Equivalent	Surgidev Corp.
K831266	MICROSURGICAL KNIFE	Jun 10, 1983	Substantially Equivalent	Vxtra Corp.
K830366	DIAMOND KNIFE	Mar 09, 1983	Substantially Equivalent	Koi, Inc.
K822112	OPHTHALMIC KNIFE	Aug 10, 1982	Substantially Equivalent	Sharpoint, Inc.
K821440	V LANCE	Jun 14, 1982	Substantially Equivalent	Sharpoint, Inc.
K820618	MICROSURGERY KNIFE	Apr 09, 1982	Substantially Equivalent	Visitec Co.
K812918	PILLING K KNIFE	Nov 06, 1981	Substantially Equivalent	Narco Scientific
K812620	ADJUSTABLE MICROSURGICAL KNIFE	Oct 19, 1981	Substantially Equivalent	Vxtra Corp.
K812450	KOI DIAMOND KNIFE	Sep 21, 1981	Substantially Equivalent	Koi, Inc.
K791981	SWAN KNIFE NEEDLE 1.5MM CAT # 1170	Oct 04, 1979	Substantially Equivalent	Edward Weck, Inc.
K791980	TOME'S #'S 1221,1222,1223,1314,6640,6642	Oct 04, 1979	Substantially Equivalent	Edward Weck, Inc.
K781465	MICROSURGICAL KNIVES, 20, 30, 45	Sep 20, 1978	Substantially Equivalent	Codman & Shurtleff, Inc.
K760191	KNIFE, TROUTMAN CORNEAL LARGE	Aug 04, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.
K760187	KNIFE, TROUTMAN CORNEAL SMALL	Aug 04, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.
K760186	DISSECTOR, TROUTMAN CORNEAL	Aug 04, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.