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510(k) K884043

GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE by Grieshaber & Co. — Product Code HQE

K884043 is an FDA 510(k) premarket notification submitted by Grieshaber & Co. for the device "GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE". The FDA issued a decision of Substantially Equivalent on November 16, 1988. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Grieshaber & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1988
Date Received
September 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
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)
  • K890782 — GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) (June 23, 1989)
  • K890783 — GRIESHABER VISCOELASTIC INJECTION SYSTEM (May 16, 1989)

Other clearances for product code HQE

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • K170183 — Cetus system, Cetus probe (September 27, 2017)
  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121675 — VERSAVIT (June 21, 2012)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)

FDA data resources