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510(k) K820933

CILCO I/A HANDPIECE by Cilco, Inc. — Product Code HQE

K820933 is an FDA 510(k) premarket notification submitted by Cilco, Inc. for the device "CILCO I/A HANDPIECE". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Cilco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
April 2, 1982
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 Cilco, Inc.

  • K861334 — CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE (May 2, 1986)
  • K854969 — CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) (February 27, 1986)
  • K844249 — K-SOL (April 30, 1985)
  • K843319 — CILCO I/A SURGICAL PACK (February 14, 1985)
  • K843992 — CILCOR OPHTHALMIC INSTRUMENTS (November 21, 1984)
  • K843447 — CILCO DIAMOND KNIFE (October 5, 1984)
  • K841099 — OCTOPUS 500/500E (June 19, 1984)
  • K840475 — CYSTOTOME, 140-S (April 5, 1984)
  • K832405 — OPTHALMIC ENDOSCOPE (November 21, 1983)
  • K827371 — CILCO ASCAN (July 9, 1982)

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