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510(k) K935003

ELECTRIC I/V POLE OR EIVP2 by Optical Micro Systems, Inc. — Product Code KYG

K935003 is an FDA 510(k) premarket notification submitted by Optical Micro Systems, Inc. for the device "ELECTRIC I/V POLE OR EIVP2". The FDA issued a decision of Substantially Equivalent on January 25, 1994. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. Optical Micro Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1994
Date Received
October 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Irrigation, Ocular Surgery
Device Class
Class I
Regulation Number
886.4360
Review Panel
OP
Submission Type

Other clearances by Optical Micro Systems, Inc.

  • K950218 — OMS SLIMLINE PHACO HANDPIECE (July 17, 1995)
  • K946054 — DIPLOMAX (July 11, 1995)
  • K935223 — OPHTHALMIC SURGICAL SYSTEM (March 14, 1994)
  • K935226 — I/V POLE (February 16, 1994)
  • K870068 — ASPIRATION REVERSAL CONTROL (ARC) MODULE (February 12, 1987)
  • K844373 — O.M.S. ULTRA-PHACO (December 19, 1985)
  • K844448 — OMS/GONVERS RETINAL PERFORATOR (August 21, 1985)
  • K844895 — OMS SILICONE OIL INJECTOR (June 24, 1985)
  • K844467 — OMS CRYO (February 22, 1985)
  • K844715 — VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY (January 22, 1985)

Other clearances for product code KYG

  • K010353 — MED-LOGICS DISPOSABLE ALK TUBING (April 27, 2001)
  • K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10102 (December 22, 2000)
  • K993591 — BLADEWORKS DISPOSABLE ALK TUBING (December 28, 1999)
  • K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM (May 19, 1998)
  • K980647 — EYE IRRIGATOR MODEL #2020 (May 15, 1998)
  • K974561 — MOISTAIR FLUID AIR TUBING SET (February 19, 1998)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)
  • K970161 — HEDGES CORNEAL WETTING PAK (March 25, 1997)
  • K954842 — D.O.R.C. VFI/VFE SYSTEM (April 15, 1996)
  • K945171 — DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (February 8, 1995)

FDA data resources