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FDA 510(k)

iovera system

K-Number: K161835 · 2017-03-24

ApplicantMyoscience, Inc.
Decision Date2017-03-24
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

iovera system is the device name listed in this FDA 510(k) record. The listed applicant is Myoscience, Inc.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K161835. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iovera system?

iovera system is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Myoscience, Inc.. The 510(k) number is K161835.

When did iovera system receive FDA 510(k) clearance?

iovera system received FDA 510(k) clearance on 2017-03-24, under 510(k) number K161835.

Who is the listed applicant for iovera system?

The FDA 510(k) record lists Myoscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iovera system?

The FDA product code for iovera system is GXH.

Other records listing Myoscience, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173763iovera system

Related Devices (Code: GXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.K243677iovera° SystemPacira Biosciences, Inc.K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)AtriCure, Inc.K220656iovera SystemPacira Biosciences, Inc.K211334Iovera SystemPacira Pharmaceuticals, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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