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510(k) K890782

GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) by Grieshaber & Co. — Product Code HMX

K890782 is an FDA 510(k) premarket notification submitted by Grieshaber & Co. for the device "GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)". The FDA issued a decision of Substantially Equivalent on June 23, 1989. The device falls under product code HMX (Cannula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Grieshaber & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
February 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
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)
  • K914587 — GRIESHABER AIR/FLUID TUBING SET (January 23, 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)
  • 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 HMX

  • K010305 — WEISS RETINAL CANNULA (May 2, 2001)
  • K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAM (May 9, 2000)
  • K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (May 20, 1997)
  • K943932 — STERISEAL OPHTHALMIC CANNULA (January 18, 1995)
  • K942403 — INFUSION CANNULA (August 17, 1994)
  • K934844 — INTER TIP T (April 19, 1994)
  • K930113 — KIRWAN IRRIGATION/ASPIRATION HANDPIECE (February 17, 1994)
  • K921488 — ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION (May 7, 1992)
  • K915074 — IRRIGATOR/ASPIRATOR PROBE (February 5, 1992)
  • K904074 — VITREORETINAL INFUSION CANNULA (February 26, 1991)

FDA data resources