# K103017: Mederi Therapeutics RF Generator Control Module

- Pathway: 510(k) (Traditional)
- Applicant: Mederi Therapeutics, Inc.
- Decided: Jan 20, 2011 after 100 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: 3 generations back to K933157 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000245: CSM Stretta System, Conway Stuart Medical, Inc. (2000) Summary page 1.
- K010210: Control Module Algorithm Enhancement for the Model S500-ST and Model S400, Curon Medical, Inc. (2001)
- K014216: Secca System, Curon Medical, Inc. (2002)

## Indications for use
The Mederi Therapeutics RF Generator is intended for general use in the electrosurgical coagulation of tissue, specifically: * The Mederi RIF Generator when used with the Secca Disposable Handpiece is intended for the treatment of bowel incontinence in patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy. * The Mederi RF Generator when used with the Stretta Disposable Catheter is intended for the treatment of gastroesophageal reflux disease (GERD).

Source page: https://510kreport.com/device/K103017
Methodology: https://510kreport.com/methodology