Product Code: HOZ FDA class 2 21 CFR 886.4790

Sponge, Ophthalmic

Ophthalmic

An Ophthalmic Sponge is an absorbent device used during eye surgery to control bleeding, remove excess fluid, and keep the surgical field clear, available in various shapes and sizes suited to delicate intraocular and periocular procedures. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device. It carries product code HOZ and is regulated under 21 CFR 886.4790, within the Ophthalmic medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HOZ
Device Class: FDA class 2
Regulation Number: 886.4790
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 47 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K132796	SUNTOUCH EYE SPEAR	Oct 30, 2013	Substantially Equivalent	Huizhou Foryou Medical Devices Co., Ltd.
K130117	NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS	Oct 29, 2013	Substantially Equivalent	Network Medical Products, Ltd.
K091240	ALPHAMED SURGICAL SPEAR, MODEL 70-5000	Oct 23, 2009	Substantially Equivalent	Alphamed, Inc.
K082460	CENEFOM PVA SURGICAL SPEAR	Dec 15, 2008	Substantially Equivalent	Longtek Scientific Co., Ltd.
K012196	ULTRACELL ABSORBENT STICK	Aug 24, 2001	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K011191	MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES	Jun 26, 2001	Substantially Equivalent	Medtronic Xomed, Inc.
K003842	PRESCOTT'S SURGICAL SPEAR	Apr 13, 2001	Substantially Equivalent	Prescott'S, Inc.
K002279	ML EYE SPEAR, MODEL ML 27 ES	Aug 18, 2000	Substantially Equivalent	Med-Logics, Inc.
K993883	M-PACT CORNEAL LIGHT SHIELD	Dec 21, 1999	Substantially Equivalent	M-Pact Corp.
K990671	DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE	May 10, 1999	Substantially Equivalent	Hurricane Medical
K990749	SOF-SUCTION FLUID EVACUATION SYSTEM	Apr 02, 1999	Substantially Equivalent	X-Tech Medical, LLC
K982599	THE FREMSTAD RING	Feb 16, 1999	Substantially Equivalent	Ophthalmic Solutions, LLC
K974313	HYDROFERA SURGICAL SPEAR	Mar 02, 1998	Substantially Equivalent	Hydrofera, LLC
K972633	ULTRACELL SUCTION SPONGE	Dec 17, 1997	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K972693	DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR	Sep 30, 1997	Substantially Equivalent	Deroyal Industries, Inc.
K971832	IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK	Jul 31, 1997	Substantially Equivalent	M-Pact Worldwide Management Corp.
K964855	EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD	Mar 04, 1997	Substantially Equivalent	Shippert Medical Technologies Corp.
K946016	IVALON OPHTHALMIC SPONGE	Mar 22, 1995	Substantially Equivalent	Ivalon
K950241	OPHTHALMIC SPONGES	Feb 27, 1995	Substantially Equivalent	Oasis Medical, Inc.
K942642	SURGI-WIPE	Jul 15, 1994	Substantially Equivalent	Surgin Surgical Instrumentation, Inc.
K933872	VISI-SPEAR EYE SPONGE	Dec 27, 1993	Substantially Equivalent	Visitec Co.
K923922	SURGICAL SPEARS	Mar 19, 1993	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K920354	OPHTHALMIC SPONGES	Aug 05, 1992	Substantially Equivalent	Ultracell Medical Technologies, Inc.
K910707	OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS	Apr 10, 1991	Substantially Equivalent	Jedmed Instrument Co.
K902750	VISI-SWAB OPHTALMIC SPONGE	Jul 26, 1990	Substantially Equivalent	Visitec Co.
K900786	VISI-SORB ABSORBANT STICK	May 18, 1990	Substantially Equivalent	Visitec Co.
K897034	K-SPONGE	Feb 15, 1990	Substantially Equivalent	Katena Products, Inc.
K896705	VISITEC MICRO-SPONGE SPEARS	Jan 11, 1990	Substantially Equivalent	Visitec Co.
K896084	MICROSPEARS	Nov 02, 1989	Substantially Equivalent	Sparta Surgical Corp.
K896004	ALCON SURGICAL SPONGE	Nov 02, 1989	Substantially Equivalent	Alcon Laboratories
K885232	FLUID DRAINAGE WICK	Feb 08, 1989	Substantially Equivalent	Visitec Co.
K872612	SOLOS EYESITE SPONGES	Jul 31, 1987	Substantially Equivalent	Solos Ophthalmology
K852055	ASCON OPHTHALMIC SPONGE	Sep 04, 1985	Substantially Equivalent	Ascon Medical Instruments, Ltd.
K850340	EYE PROCEDURE PACK	May 22, 1985	Substantially Equivalent	Marwood Medical, Inc.
K842983	AMPCO OPTHALMIC TRAY	May 22, 1985	Substantially Equivalent	Associated Medical Products Co.
K842601	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	May 10, 1985	Substantially Equivalent	Ophthalmic Resources, Inc.
K842990	STERILE EYE SURGERY KITS	May 09, 1985	Substantially Equivalent	Biological & Environmental Control Laboratories
K850050	PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK	Apr 23, 1985	Substantially Equivalent	Professional Medical Services
K850883	SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11	Mar 20, 1985	Substantially Equivalent	Storz Instrument Co.
K841721	OPERAID SURGICAL DRAIN	Nov 21, 1984	Substantially Equivalent	Jedmed Instrument Co.
K840471	EYE SPEAR	Mar 16, 1984	Substantially Equivalent	Surgicot, Inc.
K834356	EYE SPONGE OR SPEAR	Mar 16, 1984	Substantially Equivalent	Jedmed Instrument Co.
K830262	FLORET OPHTHALMIC EYE SPEAR	Apr 06, 1983	Substantially Equivalent	Ritmed, Inc.
K802794	PRO-OPHTA STICKS	Dec 22, 1980	Substantially Equivalent	Secol Co.
K780987	SOFT SILICONE ELASTOMER SPONGE EXPLANT	Sep 28, 1978	Substantially Equivalent	Medical Instrument Research Assoc., Inc.
K780257	MICROSPEARS	Feb 23, 1978	Substantially Equivalent	Sparta Instrument Corp.
K761155	CELLULOSE EYE STICK	Dec 16, 1976	Substantially Equivalent	Winn Hirsch & Assoc.