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.
Recent Cleared Devices (20 of 47)
Showing 20 most recent of 47 cleared devices.
| 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 |
Top Applicants
- Visitec Co. — 5 clearances
- Ultracell Medical Technologies, Inc. — 4 clearances
- Jedmed Instrument Co. — 3 clearances
- Alcon Laboratories — 1 clearance
- Alphamed, Inc. — 1 clearance
