# K091440: Laparoscopic Resection Device, Model SR326L

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical
- Decided: Oct 9, 2009 after 147 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: 2 generations back to K014260 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082568: Saline Enhanced Electrosurgical Resection (Seer) Device, Bovie Medical (2008) Summary page 1.

## Indications for use
The Laparoscopic Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the laparoscopic delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K091440
Methodology: https://510kreport.com/methodology