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FDA 510(k)

CRYOSURGICAL UNIT AND ACCESSORIES

K-Number: K003050 · 2000-12-26

ApplicantCryogen, Inc.
Decision Date2000-12-26
Product CodeGEI
Advisory CommitteeSU
DecisionUnknown

Device Summary

CRYOSURGICAL UNIT AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Cryogen, Inc.. It received FDA 510(k) clearance on 2000-12-26 under 510(k) number K003050. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CRYOSURGICAL UNIT AND ACCESSORIES?

CRYOSURGICAL UNIT AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2000-12-26. The listed applicant is Cryogen, Inc.. The 510(k) number is K003050.

When did CRYOSURGICAL UNIT AND ACCESSORIES receive FDA 510(k) clearance?

CRYOSURGICAL UNIT AND ACCESSORIES received FDA 510(k) clearance on 2000-12-26, under 510(k) number K003050.

Who is the listed applicant for CRYOSURGICAL UNIT AND ACCESSORIES?

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

What is the FDA product code for CRYOSURGICAL UNIT AND ACCESSORIES?

The FDA product code for CRYOSURGICAL UNIT AND ACCESSORIES is GEI.

Related Clinical Trials

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.

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Other records listing Cryogen, 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.

K974320CRYOGEN CARDIAC CRYOSURGICAL SYSTEMK972662CRYOGEN CRYOSURGICAL SYSTEMK964971CRYOGEN CRYOSURGICAL SYSTEM

Related Devices (Code: GEI)

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.

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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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