# K181071: SIRA RFA Electrosurgical Device

- Pathway: 510(k) (Traditional)
- Applicant: Innoblative Designs, Inc.
- Decided: Jan 16, 2019 after 268 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: 5 generations back to K954171 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073495: Tissuelink Aquamantys Malleable Bipolar Sealer with Light, Tissuelink Medical, Inc. (2008) Summary page 4.

## Most influential descendants
- K232947: SIRA™ RFA Electrosurgical Device (2023), 0 descendants of its own

## Indications for use
The SIRA™ RFA Electrosurgical Device supplies energy for use in electrosurgery and is indicated for use in intraoperative coagulation and ablation of soft tissue. The SIRA™ RFA 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/K181071
Methodology: https://510kreport.com/methodology