Valleylab, Inc.
United StatesFDA applicant, unverified
- Devices
- 104
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
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.
Catalogue
Search and filter all 104 devicesShowing 1-50 of 104
FDA recalls
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.
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.
Full distribution text
- 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.
Full distribution text
- 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.
Frequently asked questions
How many devices does Valleylab, Inc. have in the registry?
The registry currently lists 104 devices for Valleylab, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Valleylab, Inc.'s devices?
Among its 50 most recently registered devices, Valleylab, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Valleylab, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Valleylab, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Valleylab, Inc.?
FDA recall records list 2 recalls initiated by Valleylab, Inc., the most recent initiated on 2003-07-16. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Valleylab, Inc. in the registry?
The most recently registered devices listed for Valleylab, Inc. include MODELS E2502B/E2525 REUSABLE HANDSWITCHING PENCILS, CUSA SYSTEM 200C, T & M ULTRASONIC SURGICAL ASPIRA., VALLEYLAB PROCISION(TM) SYSTEM and LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER.