# Valleylab, Inc.

- Location (FDA's records): Boulder, CO
- FDA decisions: 104 (1976–2009): 104 510(k) clearances
- Names in FDA's records: Valleylab, Inc. (94); Valleylab (10)
- Product codes: GEI (69), LFL (9), FRN (7), FPA (4), HGI (3), GEH (2), LBK (2), KGF (1), BWA (1), GXY (1), HGZ (1), FYD (1)
- Predicates its devices cite: 43 (27 its own); citations of its devices by later devices: 201 (27 its own)
- Recalls linked to its devices: 34 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Rita Medical Systems: 4 (https://510kreport.com/company/rita-medical-systems)
- Radionics, Inc.: 2 (https://510kreport.com/company/radionics)
- Stackhouse Assoc.: 2 (https://510kreport.com/company/stackhouse-assoc)
- Cabot Medical Corp.: 2 (https://510kreport.com/company/cabot-medical)
- Radiotherapeutics Corp.: 2 (https://510kreport.com/company/radiotherapeutics)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)
- Conmedcorp: 1 (https://510kreport.com/company/conmedcorp)
- Vivant Medical, Inc.: 1 (https://510kreport.com/company/vivant-medical)

## Firms that cite its devices most
- Covidien: 12 (https://510kreport.com/company/covidien)
- Aaron Medical Industries: 7 (https://510kreport.com/company/aaron-medical-industries)
- Aragon Surgical, Inc.: 7 (https://510kreport.com/company/aragon-surgical)
- New Deantronics Taiwan, Ltd.: 5 (https://510kreport.com/company/new-deantronics-taiwan)
- Omnisonics Medical Technologies: 5 (https://510kreport.com/company/omnisonics-medical-technologies)
- Covidien, Formerly Valleylab, A Division of Tyco H: 4 (https://510kreport.com/company/covidien-formerly-valleylab-a-division-of-tyco-h)
- Valleylab,A Division of Tyco Healthcare Group LP: 4 (https://510kreport.com/company/valleylab-a-division-of-tyco-healthcare-group)
- Gyrus Acmi, Inc.: 4 (https://510kreport.com/company/gyrus-acmi)

## Its most-cited devices
- K944602: Valleylab Force FX (1995), cited by 22
- K981916: Ligasure Vessel Sealing System (1998), cited by 16
- K981262: Cusa Excel Ultrasonic Surgical Aspirator System (1998), cited by 11
- K031011: Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 (2003), cited by 9
- K962044: Valleylab Coated Electrodes (1996), cited by 8
- K051644: Valleylab Forcetriad Electrosurgical Generator (2005), cited by 7

## Recent decisions
- K092879: Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider (Oct 16, 2009)
- K063195: Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034 and LF5044 (Nov 29, 2006)
- K053535: Vivawave Microwave Ablation System (Apr 27, 2006)
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories (Mar 15, 2006)
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories (Feb 3, 2006)
- K051644: Valleylab Forcetriad Electrosurgical Generator (Aug 11, 2005)
- K051627: Valleylab G3000 Electrosurgical Instrument (Jul 22, 2005)
- K043273: Ligasure Vessel Sealing System. Ligasure Instruments (Jan 5, 2005)

Source page: https://510kreport.com/company/valleylab