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510(k) K834437

KEATES IRRIGATION/ASPIRATION/VITREOUS by Frigitronics of Connecticut, Inc. — Product Code HQE

K834437 is an FDA 510(k) premarket notification submitted by Frigitronics of Connecticut, Inc. for the device "KEATES IRRIGATION/ASPIRATION/VITREOUS". The FDA issued a decision of Substantially Equivalent on March 30, 1984. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Frigitronics of Connecticut, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1984
Date Received
December 19, 1983
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 Frigitronics of Connecticut, Inc.

  • K891282 — MIC-100 WITH CRYOPROBES (June 15, 1989)
  • K872362 — FRIGITRONICS ACC-1000 CAPSULE CUTTER (July 27, 1987)
  • K853308 — KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 (October 4, 1985)
  • K834577 — I/A PROBE LINES (May 22, 1984)
  • K840536 — CRYO SURG 5900 (April 23, 1984)
  • K822599 — KEATES I/A SYSTEM FRIGITRONICS 4000 (October 6, 1982)
  • K811390 — CCS100 CRYOSURGICAL SYSTEM (June 16, 1981)
  • K760742 — CS-76 AND/OR CRYOCARE I (November 3, 1976)

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