# K083157: HS Amica

- Pathway: 510(k) (Traditional)
- Applicant: H.S Hospital Service S.P.A
- Decided: Sep 29, 2009 after 340 days
- Product code: NEY (System, Ablation, Microwave And 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 K861904 (1986). 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)
- K053535: Vivawave Microwave Ablation System, Valleylab (2006) Summary page 1.
- K032702: Vivatip Microwave Ablation Probe, Vivant Medical, Inc. (2003) Summary page 1.
- K042216: Cool-Tip RF Ablation System, Valleylab (2004) Summary page 1.

## Most influential descendants
- K150112: HS Amica Devices Family (2015), 2 descendants of its own
- K182605: HS AMICA devices family (2019), 1 descendant of its own
- K232072: Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18G (2024), 0 descendants of its own
- K223272: SurBlate Ablation System (2023), 0 descendants of its own

## Indications for use
HS AMICA is intended for coagulation (thermoablation) of soft tissues. Not for use in cardiac procedures.

Source page: https://510kreport.com/device/K083157
Methodology: https://510kreport.com/methodology