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510(k) K874367

VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF by Spembly Medical , Ltd. — Product Code HQO

K874367 is an FDA 510(k) premarket notification submitted by Spembly Medical , Ltd. for the device "VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF". The FDA issued a decision of Substantially Equivalent on January 4, 1988. The device falls under product code HQO (Unit, Cautery, Thermal, Ac-Powered), a Class II device regulated under 21 CFR 886.4115. Spembly Medical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1988
Date Received
October 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cautery, Thermal, Ac-Powered
Device Class
Class II
Regulation Number
886.4115
Review Panel
OP
Submission Type

Other clearances by Spembly Medical , Ltd.

  • K925129 — SELECTOR (April 23, 1993)
  • K903303 — SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES (October 11, 1990)
  • K901974 — SELECTOR ULTRASONIC SURGICAL ASPIRATOR (September 5, 1990)
  • K882568 — 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY (September 27, 1988)
  • K882962 — SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) (August 8, 1988)
  • K882963 — SPEMBLY MEDICAL 142 CRYO UNIT (August 8, 1988)
  • K840497 — OBSTETRIC PULSAR TWO CHANNEL TENS (April 16, 1984)
  • K832385 — CRYOPROBES MC-1400-CRYOSURG-CONSOLE (September 12, 1983)
  • K832334 — CRYOMEDICS 5000 CRYOSURGICAL CONSOLE (August 12, 1983)
  • K832140 — CRYOMEDICS 5000 CRYOPROBES (August 12, 1983)

Other clearances for product code HQO

  • K070871 — STARION UNIVERSAL POWER SUPPLY (April 13, 2007)
  • K043155 — STARION UNIVERSAL POWER SUPPLY (UPS) (December 9, 2004)
  • K002341 — THERMAL CAUTERY UNIT, MODEL 150 (October 23, 2000)
  • K000893 — AC POWERED THERMAL CAUTERY UNIT (June 14, 2000)
  • K971538 — MENTOR GEMINI HEMOSTATIC ERASER (July 14, 1997)
  • K962135 — D.O.R.C. MICRODIATHERMY SYSTEM (August 29, 1996)
  • K943031 — BIPOLAR ELECTROSURGICAL PENCIL (September 23, 1994)
  • K900913 — ADLER DISPOSABLE BIPOLAR CORD (April 4, 1990)
  • K852075 — SITE-MALIS BIPOLAR COAGULATOR MODULE (August 20, 1985)
  • K844775 — EFFNER-EYE CAUTERY WITH BATTERY HANDLE (August 12, 1985)

FDA data resources