HOZ · Sponge, Ophthalmic
Ophthalmic · 21 CFR 886.4790 · Class 2
Overview
| Product Code | HOZ |
|---|---|
| Device Name | Sponge, Ophthalmic |
| Regulation | 21 CFR 886.4790 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Cleared Devices (47)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132796 | SUNTOUCH EYE SPEAR | Huizhou Foryou Medical Devices Co., Ltd. | Oct 30, 2013 | SESE |
| K130117 | NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS | Network Medical Products, Ltd. | Oct 29, 2013 | SESE |
| K091240 | ALPHAMED SURGICAL SPEAR, MODEL 70-5000 | Alphamed, Inc. | Oct 23, 2009 | SESE |
| K082460 | CENEFOM PVA SURGICAL SPEAR | Longtek Scientific Co., Ltd. | Dec 15, 2008 | SESE |
| K012196 | ULTRACELL ABSORBENT STICK | Ultracell Medical Technologies, Inc. | Aug 24, 2001 | SESE |
| K011191 | MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES | Medtronic Xomed, Inc. | Jun 26, 2001 | SESE |
| K003842 | PRESCOTT'S SURGICAL SPEAR | Prescott'S, Inc. | Apr 13, 2001 | SESE |
| K002279 | ML EYE SPEAR, MODEL ML 27 ES | Med-Logics, Inc. | Aug 18, 2000 | SESE |
| K993883 | M-PACT CORNEAL LIGHT SHIELD | M-Pact Corp. | Dec 21, 1999 | SESE |
| K990671 | DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE | Hurricane Medical | May 10, 1999 | SESE |
| K990749 | SOF-SUCTION FLUID EVACUATION SYSTEM | X-Tech Medical, LLC | Apr 2, 1999 | SESE |
| K982599 | THE FREMSTAD RING | Ophthalmic Solutions, LLC | Feb 16, 1999 | SESE |
| K974313 | HYDROFERA SURGICAL SPEAR | Hydrofera, LLC | Mar 2, 1998 | SESE |
| K972633 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | Dec 17, 1997 | SESE |
| K972693 | DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR | Deroyal Industries, Inc. | Sep 30, 1997 | SESE |
| K971832 | IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK | M-Pact Worldwide Management Corp. | Jul 31, 1997 | SESE |
| K964855 | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD | Shippert Medical Technologies Corp. | Mar 4, 1997 | SESE |
| K946016 | IVALON OPHTHALMIC SPONGE | Ivalon | Mar 22, 1995 | SESE |
| K950241 | OPHTHALMIC SPONGES | Oasis Medical, Inc. | Feb 27, 1995 | SESE |
| K942642 | SURGI-WIPE | Surgin Surgical Instrumentation, Inc. | Jul 15, 1994 | SESE |
| K933872 | VISI-SPEAR EYE SPONGE | Visitec Co. | Dec 27, 1993 | SESE |
| K923922 | SURGICAL SPEARS | Ultracell Medical Technologies, Inc. | Mar 19, 1993 | SESE |
| K920354 | OPHTHALMIC SPONGES | Ultracell Medical Technologies, Inc. | Aug 5, 1992 | SESE |
| K910707 | OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS | Jedmed Instrument Co. | Apr 10, 1991 | SESE |
| K902750 | VISI-SWAB OPHTALMIC SPONGE | Visitec Co. | Jul 26, 1990 | SESE |
| K900786 | VISI-SORB ABSORBANT STICK | Visitec Co. | May 18, 1990 | SESE |
| K897034 | K-SPONGE | Katena Products, Inc. | Feb 15, 1990 | SESE |
| K896705 | VISITEC MICRO-SPONGE SPEARS | Visitec Co. | Jan 11, 1990 | SESE |
| K896084 | MICROSPEARS | Sparta Surgical Corp. | Nov 2, 1989 | SESE |
| K896004 | ALCON SURGICAL SPONGE | Alcon Laboratories | Nov 2, 1989 | SESE |
| K885232 | FLUID DRAINAGE WICK | Visitec Co. | Feb 8, 1989 | SESE |
| K872612 | SOLOS EYESITE SPONGES | Solos Ophthalmology | Jul 31, 1987 | SESE |
| K852055 | ASCON OPHTHALMIC SPONGE | Ascon Medical Instruments, Ltd. | Sep 4, 1985 | SESE |
| K850340 | EYE PROCEDURE PACK | Marwood Medical, Inc. | May 22, 1985 | SESE |
| K842983 | AMPCO OPTHALMIC TRAY | Associated Medical Products Co. | May 22, 1985 | SESE |
| K842601 | PRE-OPERATIVE OPHTHALMIC DRESSING TRAY | Ophthalmic Resources, Inc. | May 10, 1985 | SESE |
| K842990 | STERILE EYE SURGERY KITS | Biological & Environmental Control Laboratories | May 9, 1985 | SESE |
| K850050 | PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK | Professional Medical Services | Apr 23, 1985 | SESE |
| K850883 | SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 | Storz Instrument Co. | Mar 20, 1985 | SESE |
| K841721 | OPERAID SURGICAL DRAIN | Jedmed Instrument Co. | Nov 21, 1984 | SESE |
| K840471 | EYE SPEAR | Surgicot, Inc. | Mar 16, 1984 | SESE |
| K834356 | EYE SPONGE OR SPEAR | Jedmed Instrument Co. | Mar 16, 1984 | SESE |
| K830262 | FLORET OPHTHALMIC EYE SPEAR | Ritmed, Inc. | Apr 6, 1983 | SESE |
| K802794 | PRO-OPHTA STICKS | Secol Co. | Dec 22, 1980 | SESE |
| K780987 | SOFT SILICONE ELASTOMER SPONGE EXPLANT | Medical Instrument Research Assoc., Inc. | Sep 28, 1978 | SESE |
| K780257 | MICROSPEARS | Sparta Instrument Corp. | Feb 23, 1978 | SESE |
| K761155 | CELLULOSE EYE STICK | Winn Hirsch & Assoc. | Dec 16, 1976 | SESE |
Top Applicants
- Visitec Co. — 5 clearances
- Ultracell Medical Technologies, Inc. — 4 clearances
- Jedmed Instrument Co. — 3 clearances
- X-Tech Medical, LLC — 1 clearance
- Winn Hirsch & Assoc. — 1 clearance
