# K223272: SurBlate Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Mima-Pro Scientific, Inc.
- Decided: Feb 28, 2023 after 127 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: 6 generations back to K861904 (1986). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 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 4.

## Indications for use
The SurBlate™ Ablation System is intended for coagulation (thermoablation) of soft tissues. Not for use in cardiac procedures.

Source page: https://510kreport.com/device/K223272
Methodology: https://510kreport.com/methodology