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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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

What Valleylab, Inc. makes

Catalogue104

Force 10, 20, 30, And 40 Ref K905605

E7512 Premie Rem Polyhesive Ii Patient Return Electrode Ref K994428

E2590 - B, Argon Accessory With Blade Electrode And E2590 - N, Argon Accessory With Needle Electrode Ref K962690

Cusa Excel Ultrasonic Surgical Aspirator System Ref K981262

Cool-Tip Rf Generator, Cool-Tip Rf System Accessories Ref K053290

Valleylab G3000 Electrosurgical Instrument Ref K051627

Valleylab Coated Electrodes Ref K962044

Valley Model E2750-T Pencil Grip Laparoscopic Ref K941968

Valleylab I.V. Administration Sets Ref K883318

Valleylab Force Gsu Handset Adapter Model #E0500 Ref K933181

Surgistat Ref K922206

Valleylab Current Monitor, E3350 & E3351 Ref K926415

E0520-Trigger Switch And Cord/E0521-Trigger Switch Ref K970140

E3590, Smoke Evacuation Attchment For Electrosurgical Pencils Ref K945260

Valleylab Optimumm Smoke Evacuator System Ref K980915

VL2600 Handswitching Pencil With Holster Ref K955109

Force Argon Ii Argon Enhanced Electrosurgical System Ref K964636

Valleylab Force 300 Ref K953195

IVSK09 Calibration Kit An Accessory To IV7000/7200 Ref K890786

Valleylab Coated Electrodes Ref K955836

Model C2100-Series Ophthalmic Cryoprobe Ref K810409

Force Gsu Tm System And Force Gsu Tm Handset Ref K904545

Valleylab Retractable Electrodes Ref K931028

Lectrovac, Valleylab Models Ref K791752

Valleylab Return Electrode Monitor Ref K801153

Force Gsu System W/ Laparoscopic Option Ref K922090

Model SSE4 Electrosurgical Generator Ref K823924

Cryosurgical Device 2000 Ref K781956

Ligasure 5mm Laparoscopic Sealer-Divider, Model LS1500 Ref K031011

Model IV6000 Infusion Pump Ref K790332

Cusa(R) Syst 200CT/200T Ultra Aspir Lap/Cem Access Ref K934628

Model Iv 1500 Standard Burette Ref K781637

E2550 Reusable Handswitching Pencil Ref K942183

Disposable Plastic Transfus./Infus. Assb Ref K822354

E600B Footswitch Ref K874794

Polyhesive Patient Return Electrode Ref K822572

Sterile Polyhesive Pbs Dressing Ref K890021

Electrode, Model E7504 Prep Ii Ref K790296

Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure Generator Ref K010010

Ligasure Advance Laparoscopic Sealer/Divider With Dissecting Electrode, Models LF5034 And LF5044 Ref K063195

Force 1C Ref K921222

Model Iv 6500 Formulator Ref K792142

Cusa System 200C And 200T Ultrasonic Aspirator Ref K921251

Ligasure Laparoscopic Sealer Divider Model LS1100 Ref K010013

Infusion Equipment, Intravenous Ref K760370

Specialty Set Model IV7A01 Ref K830891

Bisure Laparoscopic Bipolar Forceps Ref K983743

Infutrol 7000 Infusion Pump Ref K832008

VL7600 Rem Patient Return Electrode Ref K953737

Valleylab Laparoscopic Handswitch/Electrodes Ref K904560

FDA recalls2