# K974521: Vnus Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Vnus Medical Technologies, Inc.
- Decided: Feb 20, 1998 after 80 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943450 (1995). 19 ancestors in all.
977 later devices descend from it; 6 cite it directly.
0 of 997 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971532: Arthrocare Electrosurgery System, Arthrocare Corp. (1997) Summary page 1.
- K972350: Model 50 Bipolar Coagulator, Boston Surgical Products, Inc. (1997) Summary page 1.
- K971711: Somnus Model 215 Electrosurgical Generator, Somnus Medical Technologies, Inc. (1997) Summary page 1.
- K964143: Mini-Symm Bipolar Coagulator, Valley Forge Scientific Corp. (1997) Summary page 1.
- K972299: Bergen Model 500 Electrosurgery Generator, Bergen Mfg. (1997) Summary page 1.
- K964736: Bergen 610 Bipolar Coagulator, Bergen Mfg. (1997) Summary page 1.
- K971341: Kirwan Model 28 1000 Bipolar Coagulator, Kirwan Surgical Products, Inc. (1997) Summary page 1.

## Most influential descendants
- K982816: Vnus Closure System (1999), 973 descendants of its own
- K012398: Diomed 15 Diode Laser (2002), 714 descendants of its own
- K022266: Aurora SR (2002), 705 descendants of its own
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System (2002), 695 descendants of its own
- K030186: Polris LV (2003), 680 descendants of its own

## Indications for use
The VNUS Closure™ System is indicated for use in the coagulation of blood vessels during general surgery.

Source page: https://510kreport.com/device/K974521
Methodology: https://510kreport.com/methodology