# K232947: SIRA™ RFA Electrosurgical Device

- Pathway: 510(k) (Special)
- Applicant: Innoblative Designs, Inc.
- Decided: Dec 12, 2023 after 83 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 K954171 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181071: SIRA RFA Electrosurgical Device, Innoblative Designs, Inc. (2019) Summary page 4.

## Indications for use
The SIRATM RFA Electrosurgical Device supplies energy for use in electrosurgery and is indicated for use in intraoperative coagulation and ablation of soft tissue. The SIRATM RFA Electrosurgical Device is to be used in conjunction with a radiofrequency (RF) electrosurgical generator for use in open abdominal surgical procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K232947
Methodology: https://510kreport.com/methodology