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510(k) K862188

IRRIGATION & ASPIRATION/VITRECTOMY DEVICE by Coburn Optical Ind., Inc. — Product Code HQE

K862188 is an FDA 510(k) premarket notification submitted by Coburn Optical Ind., Inc. for the device "IRRIGATION & ASPIRATION/VITRECTOMY DEVICE". The FDA issued a decision of Substantially Equivalent on August 21, 1986. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Coburn Optical Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1986
Date Received
June 9, 1986
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 Coburn Optical Ind., Inc.

  • K892347 — MAGNILINK SYSTEM 101 (May 26, 1989)
  • K892349 — MAGNILINK SYSTEM 209 (May 26, 1989)
  • K892351 — MAGNILINK SYSTEM 602 (May 26, 1989)
  • K892348 — MAGNILINK SYSTEM 201 (May 26, 1989)
  • K892350 — MAGNILINK SYSTEM 402/5 (May 26, 1989)
  • K853457 — COBURN I/A SYSTEM (October 15, 1985)
  • K821737 — DISP. MICROSURGICAL KNIVES (July 2, 1982)
  • K812441 — DI-CROWN (October 6, 1981)
  • K803159 — AUTOMATED PERIMETERS (February 4, 1981)
  • K801659 — BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE (September 9, 1980)

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