HOZ — Sponge, Ophthalmic Class II
FDA product code HOZ covers "Sponge, Ophthalmic", a Class II medical device regulated under 21 CFR 886.4790. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HOZ
- Device Class
- Class II
- Regulation Number
- 886.4790
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K132796 | huizhou foryou medical devices co | SUNTOUCH EYE SPEAR | October 30, 2013 |
| K130117 | network medical products | NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS | October 29, 2013 |
| K091240 | alphamed | ALPHAMED SURGICAL SPEAR, MODEL 70-5000 | October 23, 2009 |
| K082460 | longtek scientific co | CENEFOM PVA SURGICAL SPEAR | December 15, 2008 |
| K012196 | ultracell medical technologies | ULTRACELL ABSORBENT STICK | August 24, 2001 |
| K011191 | medtronic xomed | MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES | June 26, 2001 |
| K003842 | prescott | PRESCOTT'S SURGICAL SPEAR | April 13, 2001 |
| K002279 | med-logics | ML EYE SPEAR, MODEL ML 27 ES | August 18, 2000 |
| K993883 | m-pact | M-PACT CORNEAL LIGHT SHIELD | December 21, 1999 |
| K990671 | hurricane medical | DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIP | May 10, 1999 |
| K990749 | x-tech medical | SOF-SUCTION FLUID EVACUATION SYSTEM | April 2, 1999 |
| K982599 | ophthalmic solutions | THE FREMSTAD RING | February 16, 1999 |
| K974313 | hydrofera | HYDROFERA SURGICAL SPEAR | March 2, 1998 |
| K972633 | ultracell medical technologies | ULTRACELL SUCTION SPONGE | December 17, 1997 |
| K972693 | deroyal industries | DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR | September 30, 1997 |
| K971832 | m-pact worldwide management | IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVAL | July 31, 1997 |
| K964855 | shippert medical technologies | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD | March 4, 1997 |
| K946016 | ivalon | IVALON OPHTHALMIC SPONGE | March 22, 1995 |
| K950241 | oasis medical | OPHTHALMIC SPONGES | February 27, 1995 |
| K942642 | surgin surgical instrumentation | SURGI-WIPE | July 15, 1994 |