CRYO-TOUCH IV— 510(k) K123516

Substantially Equivalent

Myoscience, Inc.

FDA 510(k) clearance K123516 for CRYO-TOUCH IV, Substantially Equivalent on 2013-01-10. Applicant: Myoscience, Inc.. Device class: 2.

Clearance details

Applicant: Myoscience, Inc.
Product code: Code GXH
Device class: Class 2
Regulation: 21 CFR 882.4250
Advisory panel: Neurology
Date received: 2012-11-14
Decision date: 2013-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Myoscience, Inc.

K173763 — iovera system2018-02-28
K161835 — iovera system2017-03-24
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K133453 — IOVERA2014-03-24
K120415 — CRYO-TOUCH III2012-06-22

Recalls naming K123516

K-number listed on FDA's recall record

Z-1781-2013 — Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue.Class II·Terminated·Myoscience Inc·20130621

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123516.

Data sourced from openFDA. This site is unofficial and independent of the FDA.