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FDA 510(k)

COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL

K-Number: K070446 · 2007-05-02

ApplicantValleylab,A Division of Tyco Healthcare Group LP
Decision Date2007-05-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab,A Division of Tyco Healthcare Group LP. It received FDA 510(k) clearance on 2007-05-02 under 510(k) number K070446. 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 SWITCHING CONTROLLER, CTSW CONTROL?

COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL is a medical device that received FDA 510(k) clearance on 2007-05-02. The listed applicant is Valleylab,A Division of Tyco Healthcare Group LP. The 510(k) number is K070446.

When did COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL receive FDA 510(k) clearance?

COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL received FDA 510(k) clearance on 2007-05-02, under 510(k) number K070446.

Who is the listed applicant for COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL?

The FDA 510(k) record lists Valleylab,A Division of Tyco Healthcare Group LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL?

The FDA product code for COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL 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 Valleylab,A Division of Tyco Healthcare Group LP 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.

K070162FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS

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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