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FDA 510(k)

CRYO-TOUCH II

K-Number: K102021 · 2010-09-17

ApplicantMyoscience, Inc.
Decision Date2010-09-17
Product CodeGXH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRYO-TOUCH II is the device name listed in this FDA 510(k) record. The listed applicant is Myoscience, Inc.. It received FDA 510(k) clearance on 2010-09-17 under 510(k) number K102021. 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 CRYO-TOUCH II?

CRYO-TOUCH II is a medical device that received FDA 510(k) clearance on 2010-09-17. The listed applicant is Myoscience, Inc.. The 510(k) number is K102021.

When did CRYO-TOUCH II receive FDA 510(k) clearance?

CRYO-TOUCH II received FDA 510(k) clearance on 2010-09-17, under 510(k) number K102021.

Who is the listed applicant for CRYO-TOUCH II?

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 CRYO-TOUCH II?

The FDA product code for CRYO-TOUCH II is GXH.

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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 systemK161835iovera systemK123516CRYO-TOUCH IVK120415CRYO-TOUCH IIIK100447MYOSCIENCE CRYO-TOUCHK083493MYOSCIENCE CRYO-TOUCH

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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

View on FDA Database →

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

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