Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4790](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4790) → HOZ — Sponge, Ophthalmic # HOZ · Sponge, Ophthalmic _Ophthalmic · 21 CFR 886.4790 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ ## Overview - **Product Code:** HOZ - **Device Name:** Sponge, Ophthalmic - **Regulation:** [21 CFR 886.4790](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4790) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) ## 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](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K132796.md) | SUNTOUCH EYE SPEAR | Huizhou Foryou Medical Devices Co., Ltd. | Oct 30, 2013 | SESE | | [K130117](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K130117.md) | NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS | Network Medical Products, Ltd. | Oct 29, 2013 | SESE | | [K091240](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K091240.md) | ALPHAMED SURGICAL SPEAR, MODEL 70-5000 | Alphamed, Inc. | Oct 23, 2009 | SESE | | [K082460](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K082460.md) | CENEFOM PVA SURGICAL SPEAR | Longtek Scientific Co., Ltd. | Dec 15, 2008 | SESE | | [K012196](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K012196.md) | ULTRACELL ABSORBENT STICK | Ultracell Medical Technologies, Inc. | Aug 24, 2001 | SESE | | [K011191](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K011191.md) | MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES | Medtronic Xomed, Inc. | Jun 26, 2001 | SESE | | [K003842](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K003842.md) | PRESCOTT'S SURGICAL SPEAR | Prescott'S, Inc. | Apr 13, 2001 | SESE | | [K002279](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K002279.md) | ML EYE SPEAR, MODEL ML 27 ES | Med-Logics, Inc. | Aug 18, 2000 | SESE | | [K993883](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K993883.md) | M-PACT CORNEAL LIGHT SHIELD | M-Pact Corp. | Dec 21, 1999 | SESE | | [K990671](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K990671.md) | DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE | Hurricane Medical | May 10, 1999 | SESE | | [K990749](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K990749.md) | SOF-SUCTION FLUID EVACUATION SYSTEM | X-Tech Medical, LLC | Apr 2, 1999 | SESE | | [K982599](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K982599.md) | THE FREMSTAD RING | Ophthalmic Solutions, LLC | Feb 16, 1999 | SESE | | [K974313](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K974313.md) | HYDROFERA SURGICAL SPEAR | Hydrofera, LLC | Mar 2, 1998 | SESE | | [K972633](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K972633.md) | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | Dec 17, 1997 | SESE | | [K972693](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K972693.md) | DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR | Deroyal Industries, Inc. | Sep 30, 1997 | SESE | | [K971832](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K971832.md) | 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](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K964855.md) | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD | Shippert Medical Technologies Corp. | Mar 4, 1997 | SESE | | [K946016](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K946016.md) | IVALON OPHTHALMIC SPONGE | Ivalon | Mar 22, 1995 | SESE | | [K950241](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K950241.md) | OPHTHALMIC SPONGES | Oasis Medical, Inc. | Feb 27, 1995 | SESE | | [K942642](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ/K942642.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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