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Valleylab, Inc.

Also registered as Valleylab

United StatesFDA applicant, unverified

Devices
104
FDA recalls
2

What Valleylab, Inc. makes

Valleylab, Inc. manufactures reusable and disposable electrosurgical tools, including handswitching pencils, ultrasonic surgical aspirators (e.g., CUSA systems), bayonet electrodes, and electrocautery accessories. Their portfolio also covers laser sonics devices, muscle stimulation electrodes, and disposable metal/plastic electrosurgical instruments. The company produces systems for precision tissue management, such as the Procision system, and specialized electrodes for electrosurgery and electrotherapy applications.

The company’s devices are classified under FDA categories Class I, Class II, Class III, and Unclassified (U), with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry. Valleylab, Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue104

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Showing 101-104 of 104

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Valleylab, Inc., initiated on 2003-07-16. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2003

    • 16 Jul 2003 Z-1121-03 Unclassified (pre-2012) Terminated Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn. Distribution: Nationwide. VA Hospital, San Antonio, TX. Foreign distribution to Australia, Brazil, Canada, Dominican Republic, France,…
      Full distribution text Nationwide. VA Hospital, San Antonio, TX. Foreign distribution to Australia, Brazil, Canada, Dominican Republic, France, Germany, Hong Kong, India, Israel, Japan, Korea, Phillipines, Singapore, Taiwan.
      Submission number: K000079
    • 16 Jul 2003 Z-1122-03 Unclassified (pre-2012) Terminated Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn. Distribution: Nationwide. VA Hospital, San Antonio, TX. Foreign distribution to Australia, Brazil, Canada, Dominican Republic, France,…
      Full distribution text Nationwide. VA Hospital, San Antonio, TX. Foreign distribution to Australia, Brazil, Canada, Dominican Republic, France, Germany, Hong Kong, India, Israel, Japan, Korea, Phillipines, Singapore, Taiwan.
      Submission number: K000079