# Coalescent Surgical

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 9 (2000–2004): 9 510(k) clearances
- Product codes: FZP (7), NJU (1), NCA (1)
- Predicates its devices cite: 35 (25 its own); citations of its devices by later devices: 54 (25 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Elective Vascular Intervention Inc. (Evi): 5 (https://510kreport.com/company/elective-vascular-intervention-evi)
- ETHICON, Inc.: 3 (https://510kreport.com/company/ethicon)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- St. Jude Medical Cardiovascular Group, Inc.: 1 (https://510kreport.com/company/st-jude-medical-cardiovascular-group)

## Firms that cite its devices most
- Medtronic Vascular: 14 (https://510kreport.com/company/medtronic-vascular)
- Medtronic, Inc.: 6 (https://510kreport.com/company/medtronic)
- Anson Medical, Ltd.: 2 (https://510kreport.com/company/anson-medical)
- Cardica, Inc.: 2 (https://510kreport.com/company/cardica)
- Lsi Solutions: 1 (https://510kreport.com/company/lsi-solutions)
- Niti Medical Technologies, Ltd.: 1 (https://510kreport.com/company/niti-medical-technologies)
- Medtronic Neurosurgery: 1 (https://510kreport.com/company/medtronic-neurosurgery)
- AtriCure, Inc.: 1 (https://510kreport.com/company/atricure)

## Its most-cited devices
- K994160: Coalescent Surgical Sutured-Clip (2000), cited by 11
- K012317: Coalescent Surgical U-Clip (2001), cited by 10
- K013664: Coalescent Surgical U-Clip (2002), cited by 9
- K021407: Coalescent Surgical U-Clip - or Other TBD and Accessories (2002), cited by 7
- K024366: Coalescent Surgical U-Clip and Accessories (2003), cited by 6
- K023125: Coalescent U-Clip- and Accessories (2002), cited by 6

## Recent decisions
- K040821: Coalescent Surgical U-Clip and Accessories (Apr 23, 2004)
- K031623: Modification to Coalescent Surgical U-Clip and Accessories (Jul 3, 2003)
- K024366: Coalescent Surgical U-Clip and Accessories (Jan 17, 2003)
- K023125: Coalescent U-Clip- and Accessories (Dec 18, 2002)
- K021407: Coalescent Surgical U-Clip - or Other TBD and Accessories (Jul 3, 2002)
- K013664: Coalescent Surgical U-Clip (Jan 24, 2002)
- K012317: Coalescent Surgical U-Clip (Aug 31, 2001)
- K003958: Coalescent U-Clip Delivery and Disposal Device (Feb 6, 2001)

Source page: https://510kreport.com/company/coalescent-surgical