Atlas FDA

HOZ

47 FDA 510(k) clearances · Product code

73 daysmedian time to decision
226 days90th percentile
47clearances measured

FDA profile

Official device name
Sponge, Ophthalmic
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4790
Medical specialty
Ophthalmic
Adverse events (MAUDE)
1997: 3 · 1998: 1 · 2000: 1 · 2001: 4 · 2002: 22 · 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SUNTOUCH EYE SPEAR (K132796)Huizhou Foryou Medical Devices Co., Ltd.2013-10-30
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (K130117)Network Medical Products, Ltd.2013-10-29
ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (K091240)Alphamed, Inc.2009-10-23
CENEFOM PVA SURGICAL SPEAR (K082460)Longtek Scientific Co., Ltd.2008-12-15
ULTRACELL ABSORBENT STICK (K012196)Ultracell Medical Technologies, Inc.2001-08-24
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES (K011191)Medtronic Xomed, Inc.2001-06-26
PRESCOTT'S SURGICAL SPEAR (K003842)Prescott'S, Inc.2001-04-13
ML EYE SPEAR, MODEL ML 27 ES (K002279)Med-Logics, Inc.2000-08-18
M-PACT CORNEAL LIGHT SHIELD (K993883)M-Pact Corp.1999-12-21
DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE (K990671)Hurricane Medical1999-05-10
SOF-SUCTION FLUID EVACUATION SYSTEM (K990749)X-Tech Medical, LLC1999-04-02
THE FREMSTAD RING (K982599)Ophthalmic Solutions, LLC1999-02-16
HYDROFERA SURGICAL SPEAR (K974313)Hydrofera, LLC1998-03-02
ULTRACELL SUCTION SPONGE (K972633)Ultracell Medical Technologies, Inc.1997-12-17
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR (K972693)Deroyal Industries, Inc.1997-09-30
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK (K971832)M-Pact Worldwide Management Corp.1997-07-31
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD (K964855)Shippert Medical Technologies Corp.1997-03-04
IVALON OPHTHALMIC SPONGE (K946016)Ivalon1995-03-22
OPHTHALMIC SPONGES (K950241)Oasis Medical, Inc.1995-02-27
SURGI-WIPE (K942642)Surgin Surgical Instrumentation, Inc.1994-07-15
VISI-SPEAR EYE SPONGE (K933872)Visitec Co.1993-12-27
SURGICAL SPEARS (K923922)Ultracell Medical Technologies, Inc.1993-03-19
OPHTHALMIC SPONGES (K920354)Ultracell Medical Technologies, Inc.1992-08-05
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS (K910707)Jedmed Instrument Co.1991-04-10
VISI-SWAB OPHTALMIC SPONGE (K902750)Visitec Co.1990-07-26
VISI-SORB ABSORBANT STICK (K900786)Visitec Co.1990-05-18
K-SPONGE (K897034)Katena Products, Inc.1990-02-15
VISITEC MICRO-SPONGE SPEARS (K896705)Visitec Co.1990-01-11
MICROSPEARS (K896084)Sparta Surgical Corp.1989-11-02
ALCON SURGICAL SPONGE (K896004)Alcon Laboratories1989-11-02
FLUID DRAINAGE WICK (K885232)Visitec Co.1989-02-08
SOLOS EYESITE SPONGES (K872612)Solos Ophthalmology1987-07-31
ASCON OPHTHALMIC SPONGE (K852055)Ascon Medical Instruments, Ltd.1985-09-04
AMPCO OPTHALMIC TRAY (K842983)Associated Medical Products Co.1985-05-22
EYE PROCEDURE PACK (K850340)Marwood Medical, Inc.1985-05-22
PRE-OPERATIVE OPHTHALMIC DRESSING TRAY (K842601)Ophthalmic Resources, Inc.1985-05-10
STERILE EYE SURGERY KITS (K842990)Biological & Environmental Control Laboratories1985-05-09
PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK (K850050)Professional Medical Services1985-04-23
SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 (K850883)Storz Instrument Co.1985-03-20
OPERAID SURGICAL DRAIN (K841721)Jedmed Instrument Co.1984-11-21
EYE SPONGE OR SPEAR (K834356)Jedmed Instrument Co.1984-03-16
EYE SPEAR (K840471)Surgicot, Inc.1984-03-16
FLORET OPHTHALMIC EYE SPEAR (K830262)Ritmed, Inc.1983-04-06
PRO-OPHTA STICKS (K802794)Secol Co.1980-12-22
SOFT SILICONE ELASTOMER SPONGE EXPLANT (K780987)Medical Instrument Research Assoc., Inc.1978-09-28
MICROSPEARS (K780257)Sparta Instrument Corp.1978-02-23
CELLULOSE EYE STICK (K761155)Winn Hirsch & Assoc.1976-12-16

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