# K213814: Viveve 2.0 System

- Pathway: 510(k) (Traditional)
- Applicant: Viveve, Inc.
- Decided: Feb 2, 2022 after 57 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: 15 generations back to K943450 (1995). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212678: Viveve System, Viveve 2.0 System, Viveve Medical, Inc. (2021) Summary page 4.

## Indications for use
The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K213814
Methodology: https://510kreport.com/methodology