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510(k) K033390

COLIBRI DISPOSABLE VITRECTOMY CUTTER by Microworld Medical Instruments, Inc. — Product Code HQE

K033390 is an FDA 510(k) premarket notification submitted by Microworld Medical Instruments, Inc. for the device "COLIBRI DISPOSABLE VITRECTOMY CUTTER". The FDA issued a decision of Substantially Equivalent on November 4, 2003. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2003
Date Received
October 23, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

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  • 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)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)
  • K020911 — MID LABS AUTONOMOUS VIT ENHANCER (AVE) (April 29, 2002)

FDA data resources