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510(k) K914587

GRIESHABER AIR/FLUID TUBING SET by Grieshaber & Co. — Product Code KYG

K914587 is an FDA 510(k) premarket notification submitted by Grieshaber & Co. for the device "GRIESHABER AIR/FLUID TUBING SET". The FDA issued a decision of Substantially Equivalent on January 23, 1992. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. Grieshaber & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1992
Date Received
October 16, 1991
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 Grieshaber & Co.

  • K950056 — THE GRIESHABER AXIAL CUTTER (May 5, 1995)
  • K930842 — THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE (May 3, 1994)
  • K914588 — GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE (June 11, 1992)
  • K914586 — GRIESHABER THREE FUNCTION MANIPULATOR (January 3, 1992)
  • K914585 — GRIESHABER TWO FUNCTION MANIPULATOR (January 3, 1992)
  • K897119 — GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP (April 12, 1990)
  • K900714 — ZZIPP INSTANT BOVIE CLEANER (March 27, 1990)
  • K890782 — GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) (June 23, 1989)
  • K890783 — GRIESHABER VISCOELASTIC INJECTION SYSTEM (May 16, 1989)
  • K884043 — GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE (November 16, 1988)

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