# K150112: HS Amica Devices Family

- Pathway: 510(k) (Traditional)
- Applicant: H.S Hospital Service S.P.A
- Decided: Sep 10, 2015 after 233 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: 6 generations back to K870028 (1987). 29 ancestors in all.
2 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)
- K083157: HS Amica, H.S Hospital Service S.P.A (2009) Summary page 5.
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 5.

## Most influential descendants
- 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

## Indications for use
Coagulation (thermoablation) of soft tissue. Not for use in cardiac procedures.

Source page: https://510kreport.com/device/K150112
Methodology: https://510kreport.com/methodology