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510(k) K914585

GRIESHABER TWO FUNCTION MANIPULATOR by Grieshaber & Co. — Product Code EQH

K914585 is an FDA 510(k) premarket notification submitted by Grieshaber & Co. for the device "GRIESHABER TWO FUNCTION MANIPULATOR". The FDA issued a decision of Substantially Equivalent on January 3, 1992. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Grieshaber & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1992
Date Received
October 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Carrier, Fiberoptic Light
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
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)
  • K914587 — GRIESHABER AIR/FLUID TUBING SET (January 23, 1992)
  • K914586 — GRIESHABER THREE 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 EQH

  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K934911 — SAPHIRE PLUS SURGICAL MIRROR (June 21, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)

FDA data resources