# K212678: Viveve System, Viveve 2.0 System

- Pathway: 510(k) (Special)
- Applicant: Viveve Medical, Inc.
- Decided: Sep 14, 2021 after 21 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: 14 generations back to K943450 (1995). 30 ancestors in all.
1 later device descends from it; 1 cites 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)
- K200472: Viveve System, Viveve Medical, Inc. (2020) Summary page 4.
- K193611: Viveve 2.0 System, Viveve Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K213814: Viveve 2.0 System (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K212678
Methodology: https://510kreport.com/methodology