# K190422: Viveve System 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Viveve Medical
- Decided: Jun 12, 2019 after 111 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: 12 generations back to K943450 (1995). 27 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180584: Viveve RF System, Secure, Viveve, Inc. (2018) Summary page 4.

## Most influential descendants
- K200472: Viveve System (2020), 2 descendants of its own
- K193611: Viveve 2.0 System (2020), 2 descendants of its own
- K212678: Viveve System, Viveve 2.0 System (2021), 1 descendant of its own
- K213814: Viveve 2.0 System (2022), 0 descendants of its own

## 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/K190422
Methodology: https://510kreport.com/methodology