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510(k) K946016

IVALON OPHTHALMIC SPONGE by Ivalon — Product Code HOZ

K946016 is an FDA 510(k) premarket notification submitted by Ivalon for the device "IVALON OPHTHALMIC SPONGE". The FDA issued a decision of Substantially Equivalent on March 22, 1995. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Ivalon has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1995
Date Received
December 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type

Other clearances by Ivalon

  • K946015 — IVALON EXTERNAL SPONGE (February 27, 1995)
  • K913556 — IVALON EMBOLIZATION PARTICLES (April 13, 1994)

Other clearances for product code HOZ

  • K132796 — SUNTOUCH EYE SPEAR (October 30, 2013)
  • K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (October 29, 2013)
  • K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (October 23, 2009)
  • K082460 — CENEFOM PVA SURGICAL SPEAR (December 15, 2008)
  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K011191 — MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES (June 26, 2001)
  • K003842 — PRESCOTT'S SURGICAL SPEAR (April 13, 2001)
  • K002279 — ML EYE SPEAR, MODEL ML 27 ES (August 18, 2000)
  • K993883 — M-PACT CORNEAL LIGHT SHIELD (December 21, 1999)
  • K990671 — DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIP (May 10, 1999)

FDA data resources