FDA 510(k)

COOL-TIP RF ABLATION SYSTEM

K-Number: K042216 · 2004-11-12

Decision Date2004-11-12

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

COOL-TIP RF ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab. It received FDA 510(k) clearance on 2004-11-12 under 510(k) number K042216. 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 COOL-TIP RF ABLATION SYSTEM?

COOL-TIP RF ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-12. The listed applicant is Valleylab. The 510(k) number is K042216.

When did COOL-TIP RF ABLATION SYSTEM receive FDA 510(k) clearance?

COOL-TIP RF ABLATION SYSTEM received FDA 510(k) clearance on 2004-11-12, under 510(k) number K042216.

Who is the listed applicant for COOL-TIP RF ABLATION SYSTEM?

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

What is the FDA product code for COOL-TIP RF ABLATION SYSTEM?

The FDA product code for COOL-TIP RF ABLATION SYSTEM is GEI.

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Other records listing Valleylab as applicant

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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.