# K162547: Viveve System

- Pathway: 510(k) (Special)
- Applicant: Viveve, Inc.
- Decided: Oct 6, 2016 after 24 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: 10 generations back to K943450 (1995). 25 ancestors in all.
6 later devices descend 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)
- K082962: Tivamed Cooled RF System, Model 78001, Tivamed, Inc. (2008) Summary page 4.

## Most influential descendants
- K180584: Viveve RF System, Secure (2018), 5 descendants of its own
- K190422: Viveve System 2.0 (2019), 4 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K162547
Methodology: https://510kreport.com/methodology