# K014216: Secca System

- Pathway: 510(k) (Traditional)
- Applicant: Curon Medical, Inc.
- Decided: Mar 21, 2002 after 90 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 K933157 (1994). 12 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010210: Control Module Algorithm Enhancement for the Model S500-ST and Model S400, Curon Medical, Inc. (2001) Summary page 2.
- K000245: CSM Stretta System, Conway Stuart Medical, Inc. (2000) Summary page 1.
- K991291: Stretta Inflatable Basket Catheter Electrode with Aspiration, Conway Stuart Medical, Inc. (1999) Summary page 1.
- K000170: Secca Tubular Electrode Device, Model A4000, Conway Stuart Medical, Inc. (2000) Summary page 1.
- K992542: Tubular Electrode Device, Conway Stuart Medical, Inc. (1999) Summary page 2.
- K904646: Bci-100 Fecal Incontinence System, Biocare Intl. (1991) Summary page 2.
- K913736: Dobbhoff Anorect Biofeed Syst Five Div Fecal Const, Biosearch Medical Products, Inc. (1992) Summary page 2.
- K981361: Powerstar Bipolar Scissors, ETHICON, Inc. (1998) Summary page 2.
- K992382: Surgitron Radiolase, Ellman Intl., Inc. (1999) Summary page 2.
- K970083: Dynabite Hot GI Biopsy Forceps, Portlyn Corp. (1997) Summary page 2.

## Most influential descendants
- K110143: Het Bipolar Electrocautery Forceps (2011), 3 descendants of its own
- K121085: Het Bipolar Ligator System (2012), 2 descendants of its own
- K140422: Het Systems, LLC, Het Bipolar Ligator System (2014), 1 descendant of its own
- K200146: HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor (2020), 0 descendants of its own
- K103017: Mederi Therapeutics RF Generator Control Module (2011), 0 descendants of its own

## Indications for use
The Secca™ System is intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of fecal incontinence in those patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy.

Source page: https://510kreport.com/device/K014216
Methodology: https://510kreport.com/methodology