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510(k) K761155

CELLULOSE EYE STICK by Winn Hirsch & Assoc. — Product Code HOZ

K761155 is an FDA 510(k) premarket notification submitted by Winn Hirsch & Assoc. for the device "CELLULOSE EYE STICK". The FDA issued a decision of Substantially Equivalent on December 16, 1976. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Winn Hirsch & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1976
Date Received
November 29, 1976
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 Winn Hirsch & Assoc.

  • K880309 — TYPE 316L STAINLESS STEEL WIRE (February 29, 1988)
  • K864375 — TYPE 316L COTTER WIRE (May 20, 1987)
  • K832214 — GAUZE CONVERSION CLASS I-NON-STERILE (July 26, 1983)
  • K832213 — GAUZE CONVERSION CLASS II STERILE (July 26, 1983)
  • K830511 — ZANLEX, ZAN-TEX & ZANDEX (March 17, 1983)
  • K812390 — NEUROSPONGE PADDIE (November 24, 1981)
  • K812391 — NEUROSPONGES (November 24, 1981)
  • K800195 — COTTON UNDER CAST PADDING (February 11, 1980)
  • K760513 — ELECTRODE, TEMPORARY MYOCARDIAL (October 15, 1976)
  • K760365 — BLANKET, BURN (August 11, 1976)

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