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510(k) K950241

OPHTHALMIC SPONGES by Oasis Medical, Inc. — Product Code HOZ

K950241 is an FDA 510(k) premarket notification submitted by Oasis Medical, Inc. for the device "OPHTHALMIC SPONGES". The FDA issued a decision of Substantially Equivalent on February 27, 1995. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Oasis Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1995
Date Received
January 20, 1995
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 Oasis Medical, Inc.

  • K213988 — SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (June 3, 2022)
  • K162361 — Soft Plug Extended Duration 180 Canalicular Plug (April 17, 2017)
  • K032297 — DISPOSABLE N-PE MICKROKERATOME BLADES (August 26, 2003)
  • K030401 — DISPOSABLE M2-PE MICROKERATOME BLADES (June 19, 2003)
  • K022205 — DISPOSABLE N-PE MICROKERATOME BLADES (October 3, 2002)
  • K013613 — SOFT PLUG ABSORBABLE PLUG-SA (June 27, 2002)
  • K003820 — DISPOSABLE CB-PE MICROKERATOME BLADES (March 8, 2001)
  • K001176 — DISPOSABLE MICROKERATOME BLADES-PE (September 21, 2000)
  • K980437 — SILICONE PUNCTAL PLUG (April 30, 1998)
  • K950798 — POSTERIOR CAPSULE SHIELD (May 22, 1995)

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