Product code HOZ— Ophthalmic
MICROSPEARS
- Classification name
- Sponge, Ophthalmic
- Device class
- Class 2
- Regulation
- 21 CFR 886.4790
- Advisory panel
- Ophthalmic
- Total cleared
- 47
- First cleared
- Most recent
Market context for product code HOZ
FDA has cleared devices under product code HOZ between 1976 and 2013, filed by 38 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2013
- 2009
- 2008
- 2001
- 2000
- 1999
- 1998
- 1997
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
Top applicants under product code HOZ
Recent clearances under product code HOZ
- K132796 — SUNTOUCH EYE SPEAR
- K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
- K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-5000
- K082460 — CENEFOM PVA SURGICAL SPEAR
- K012196 — ULTRACELL ABSORBENT STICK
- K011191 — MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
- K003842 — PRESCOTT'S SURGICAL SPEAR
- K002279 — ML EYE SPEAR, MODEL ML 27 ES
- K993883 — M-PACT CORNEAL LIGHT SHIELD
- K990671 — DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE
- K990749 — SOF-SUCTION FLUID EVACUATION SYSTEM
- K982599 — THE FREMSTAD RING
- K974313 — HYDROFERA SURGICAL SPEAR
- K972633 — ULTRACELL SUCTION SPONGE
- K972693 — DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
- K971832 — IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
- K964855 — EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
- K946016 — IVALON OPHTHALMIC SPONGE
- K950241 — OPHTHALMIC SPONGES
- K942642 — SURGI-WIPE
- K933872 — VISI-SPEAR EYE SPONGE
- K923922 — SURGICAL SPEARS
- K920354 — OPHTHALMIC SPONGES
- K910707 — OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
- K902750 — VISI-SWAB OPHTALMIC SPONGE
- K900786 — VISI-SORB ABSORBANT STICK
- K897034 — K-SPONGE
- K896705 — VISITEC MICRO-SPONGE SPEARS
- K896004 — ALCON SURGICAL SPONGE
- K896084 — MICROSPEARS
- K885232 — FLUID DRAINAGE WICK
- K872612 — SOLOS EYESITE SPONGES
- K852055 — ASCON OPHTHALMIC SPONGE
- K842983 — AMPCO OPTHALMIC TRAY
- K850340 — EYE PROCEDURE PACK
- K842601 — PRE-OPERATIVE OPHTHALMIC DRESSING TRAY
- K842990 — STERILE EYE SURGERY KITS
- K850050 — PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK
- K850883 — SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11
- K841721 — OPERAID SURGICAL DRAIN
- K834356 — EYE SPONGE OR SPEAR
- K840471 — EYE SPEAR
- K830262 — FLORET OPHTHALMIC EYE SPEAR
- K802794 — PRO-OPHTA STICKS
- K780987 — SOFT SILICONE ELASTOMER SPONGE EXPLANT
- K780257 — MICROSPEARS
- K761155 — CELLULOSE EYE STICK
Data sourced from openFDA. This site is unofficial and independent of the FDA.