Home / 510(k) Clearances / K831963

510(k) K831963

CRYOMEDICS NEUROSTAT by Spembly Medical , Ltd. — Product Code GXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
June 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Surgical, Cryogenic
Device Class
Class II
Regulation Number
882.4250
Review Panel
NE
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)
  • K882963 — SPEMBLY MEDICAL 142 CRYO UNIT (August 8, 1988)
  • K882962 — SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) (August 8, 1988)
  • K874367 — VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF (January 4, 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)

Other clearances for product code GXH

  • K250371 — cryoICE cryoXT cryoablation probe (cryoXT) (April 10, 2025)
  • K243677 — iovera° System (December 26, 2024)
  • K243157 — AtriCure cryoICE BOX (ACM) (October 29, 2024)
  • K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablatio (October 26, 2023)
  • K220656 — iovera System (May 20, 2022)
  • K211334 — Iovera System (September 10, 2021)
  • K200697 — AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoa (December 23, 2020)
  • K182565 — AtriCure cryoICE cryoSPHERE cryoablation probe (November 9, 2018)
  • K173763 — iovera system (February 28, 2018)
  • K180138 — AtriCure cryoICE cryo-ablation probe (CRYO2) (February 15, 2018)