Myoscience iovera system— 510(k) K142866

Substantially Equivalent

Myoscience, Inc.

FDA 510(k) clearance K142866 for Myoscience iovera system, Substantially Equivalent on 2015-01-21. 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: 2014-10-01
Decision date: 2015-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXH

K250371 — cryoICE cryoXT cryoablation probe (cryoXT)2025-04-10
K243677 — iovera° System2024-12-26
K243157 — AtriCure cryoICE BOX (ACM)2024-10-29
K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more2023-10-26
K220656 — iovera System2022-05-20

More clearances from Myoscience, Inc.

Recalls naming K142866

K-number listed on FDA's recall record

Z-2201-2015 — iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device 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 iovera device is not indicated for treatment of central nervous system tissueClass II·Terminated·Myoscience Inc·20150701

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142866.

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