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FDA 510(k)

SOPRANO CRYO-THERAPY SYSTEM

K-Number: K980393 · 1998-05-01

ApplicantGynecare Innovation Center
Decision Date1998-05-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOPRANO CRYO-THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gynecare Innovation Center. It received FDA 510(k) clearance on 1998-05-01 under 510(k) number K980393. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPRANO CRYO-THERAPY SYSTEM?

SOPRANO CRYO-THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Gynecare Innovation Center. The 510(k) number is K980393.

When did SOPRANO CRYO-THERAPY SYSTEM receive FDA 510(k) clearance?

SOPRANO CRYO-THERAPY SYSTEM received FDA 510(k) clearance on 1998-05-01, under 510(k) number K980393.

Who is the listed applicant for SOPRANO CRYO-THERAPY SYSTEM?

The FDA 510(k) record lists Gynecare Innovation Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOPRANO CRYO-THERAPY SYSTEM?

The FDA product code for SOPRANO CRYO-THERAPY SYSTEM is GEI.

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Other records listing Gynecare Innovation Center as applicant

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Related Devices (Code: GEI)

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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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