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510(k) K091240

ALPHAMED SURGICAL SPEAR, MODEL 70-5000 by Alphamed, Inc. — Product Code HOZ

K091240 is an FDA 510(k) premarket notification submitted by Alphamed, Inc. for the device "ALPHAMED SURGICAL SPEAR, MODEL 70-5000". The FDA issued a decision of Substantially Equivalent on October 23, 2009. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Alphamed, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2009
Date Received
April 27, 2009
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 Alphamed, Inc.

  • K190210 — Tear Pool Dissolvable Punctum Plugs (October 24, 2019)
  • K990321 — ALPHAMED GEMINI SENSOR, SNORING SENSOR (June 1, 1999)
  • K926446 — EZ PUMP (September 27, 1993)

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)
  • 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)
  • K990749 — SOF-SUCTION FLUID EVACUATION SYSTEM (April 2, 1999)

FDA data resources