FDA Product Code
FDA Product Code HOZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4790
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132796 | SUNTOUCH EYE SPEAR | Huizhou Foryou Medical Devices Co., Ltd. | 2013-10-30 | Traditional | PDF ↗ |
| K130117 | NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS | Network Medical Products, Ltd. | 2013-10-29 | Traditional | PDF ↗ |
| K091240 | ALPHAMED SURGICAL SPEAR, MODEL 70-5000 | Alphamed, Inc. | 2009-10-23 | Traditional | PDF ↗ |
| K082460 | CENEFOM PVA SURGICAL SPEAR | Longtek Scientific Co., Ltd. | 2008-12-15 | Traditional | PDF ↗ |
| K012196 | ULTRACELL ABSORBENT STICK | Ultracell Medical Technologies, Inc. | 2001-08-24 | Traditional | PDF ↗ |
| K011191 | MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES | Medtronic Xomed, Inc. | 2001-06-26 | Traditional | PDF ↗ |
| K003842 | PRESCOTT'S SURGICAL SPEAR | Prescott'S, Inc. | 2001-04-13 | Traditional | PDF ↗ |
| K002279 | ML EYE SPEAR, MODEL ML 27 ES | Med-Logics, Inc. | 2000-08-18 | Traditional | PDF ↗ |
| K993883 | M-PACT CORNEAL LIGHT SHIELD | M-Pact Corp. | 1999-12-21 | Traditional | PDF ↗ |
| K990671 | DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE | Hurricane Medical | 1999-05-10 | Traditional | PDF ↗ |
| K990749 | SOF-SUCTION FLUID EVACUATION SYSTEM | X-Tech Medical, LLC | 1999-04-02 | Traditional | PDF ↗ |
| K982599 | THE FREMSTAD RING | Ophthalmic Solutions, LLC | 1999-02-16 | Traditional | PDF ↗ |
| K974313 | HYDROFERA SURGICAL SPEAR | Hydrofera, LLC | 1998-03-02 | Traditional | PDF ↗ |
| K972633 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K972693 | DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR | Deroyal Industries, Inc. | 1997-09-30 | Traditional | PDF ↗ |
| K971832 | IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK | M-Pact Worldwide Management Corp. | 1997-07-31 | Traditional | PDF ↗ |
| K964855 | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD | Shippert Medical Technologies Corp. | 1997-03-04 | Traditional | PDF ↗ |
| K946016 | IVALON OPHTHALMIC SPONGE | Ivalon | 1995-03-22 | Traditional | PDF ↗ |
| K950241 | OPHTHALMIC SPONGES | Oasis Medical, Inc. | 1995-02-27 | Traditional | PDF ↗ |
| K942642 | SURGI-WIPE | Surgin Surgical Instrumentation, Inc. | 1994-07-15 | Traditional | PDF ↗ |
| K933872 | VISI-SPEAR EYE SPONGE | Visitec Co. | 1993-12-27 | Traditional | PDF ↗ |
| K923922 | SURGICAL SPEARS | Ultracell Medical Technologies, Inc. | 1993-03-19 | Traditional | PDF ↗ |
| K920354 | OPHTHALMIC SPONGES | Ultracell Medical Technologies, Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K910707 | OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS | Jedmed Instrument Co. | 1991-04-10 | Traditional | PDF ↗ |
| K902750 | VISI-SWAB OPHTALMIC SPONGE | Visitec Co. | 1990-07-26 | Traditional | PDF ↗ |
| K900786 | VISI-SORB ABSORBANT STICK | Visitec Co. | 1990-05-18 | Traditional | PDF ↗ |
| K897034 | K-SPONGE | Katena Products, Inc. | 1990-02-15 | Traditional | PDF ↗ |
| K896705 | VISITEC MICRO-SPONGE SPEARS | Visitec Co. | 1990-01-11 | Traditional | PDF ↗ |
| K896004 | ALCON SURGICAL SPONGE | Alcon Laboratories | 1989-11-02 | Traditional | PDF ↗ |
| K896084 | MICROSPEARS | Sparta Surgical Corp. | 1989-11-02 | Traditional | PDF ↗ |
| K885232 | FLUID DRAINAGE WICK | Visitec Co. | 1989-02-08 | Traditional | PDF ↗ |
| K872612 | SOLOS EYESITE SPONGES | Solos Ophthalmology | 1987-07-31 | Traditional | PDF ↗ |
| K852055 | ASCON OPHTHALMIC SPONGE | Ascon Medical Instruments, Ltd. | 1985-09-04 | Traditional | PDF ↗ |
| K842983 | AMPCO OPTHALMIC TRAY | Associated Medical Products Co. | 1985-05-22 | Traditional | PDF ↗ |
| K850340 | EYE PROCEDURE PACK | Marwood Medical, Inc. | 1985-05-22 | Traditional | PDF ↗ |
| K842601 | PRE-OPERATIVE OPHTHALMIC DRESSING TRAY | Ophthalmic Resources, Inc. | 1985-05-10 | Traditional | PDF ↗ |
| K842990 | STERILE EYE SURGERY KITS | Biological & Environmental Control Laboratories | 1985-05-09 | Traditional | PDF ↗ |
| K850050 | PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK | Professional Medical Services | 1985-04-23 | Traditional | PDF ↗ |
| K850883 | SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 | Storz Instrument Co. | 1985-03-20 | Traditional | PDF ↗ |
| K841721 | OPERAID SURGICAL DRAIN | Jedmed Instrument Co. | 1984-11-21 | Traditional | PDF ↗ |
| K840471 | EYE SPEAR | Surgicot, Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K834356 | EYE SPONGE OR SPEAR | Jedmed Instrument Co. | 1984-03-16 | Traditional | PDF ↗ |
| K830262 | FLORET OPHTHALMIC EYE SPEAR | Ritmed, Inc. | 1983-04-06 | Traditional | PDF ↗ |
| K802794 | PRO-OPHTA STICKS | Secol Co. | 1980-12-22 | Traditional | PDF ↗ |
| K780987 | SOFT SILICONE ELASTOMER SPONGE EXPLANT | Medical Instrument Research Assoc., Inc. | 1978-09-28 | Traditional | PDF ↗ |
| K780257 | MICROSPEARS | Sparta Instrument Corp. | 1978-02-23 | Traditional | PDF ↗ |
| K761155 | CELLULOSE EYE STICK | Winn Hirsch & Assoc. | 1976-12-16 | Traditional | PDF ↗ |
Product code HOZ · Class II · Ophthalmic. Data: openFDA.