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510(k) K861013

ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) by Ameritek, Inc. — Product Code KYG

K861013 is an FDA 510(k) premarket notification submitted by Ameritek, Inc. for the device "ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)". The FDA issued a decision of Substantially Equivalent on March 31, 1986. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. Ameritek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1986
Date Received
March 18, 1986
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 Ameritek, Inc.

  • K001215 — DBEST HCG 2 IU/ML TEST KIT (June 22, 2000)
  • K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (September 1, 1999)
  • K990681 — DBSET MULTIDRUG SCREEN TEST KIT (July 15, 1999)
  • K984269 — DBEST OCCULT BLOOD TEST KIT (May 11, 1999)
  • K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT (November 18, 1998)
  • K983191 — DBEST COCAINE TEST KIT (November 18, 1998)
  • K983189 — DBEST METHAMPHETAMINES TEST KIT (November 18, 1998)
  • K983190 — DBEST OPIATES TEST KIT (November 18, 1998)
  • K981504 — DBEST AMPHETAMINES TEST KIT (August 6, 1998)
  • K974508 — DBEST ONE-STEP OVULATION TEST (February 2, 1998)

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