# K991529: CSM Stretta Control Module Electrosurgical Generator, Model S400

- Pathway: 510(k) (Traditional)
- Applicant: Conway Stuart Medical, Inc.
- Decided: Sep 14, 1999 after 134 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Conway Stuart Medical Model C4: named in the summary without a submission number

## Indications for use
The Stretta Control Module Model S400 RF electrosurgical generator with pump, in combination with CSM electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.

Source page: https://510kreport.com/device/K991529
Methodology: https://510kreport.com/methodology