# K003956: Bard Endocinch Suturing System # 000452; 000454; 000595

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 5, 2001 after 15 days
- Product code: ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd))
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 6 cite it directly.
0 of 33 devices 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) Bard® Endoscopic Suturing System: named in the summary without a submission number
- (no number) Y-Knot Suture Clip: named in the summary without a submission number
- (no number) SutureLok: named in the summary without a submission number

## Most influential descendants
- K062875: Endogastric Stomaphyx Device and Accessories (2007), 21 descendants of its own
- K071651: Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories (2007), 15 descendants of its own
- K061770: Ethicon Endo Surgery Endoscopic Suturing System (2006), 14 descendants of its own
- K081853: Overstitch Endoscopic Suture System (2008), 8 descendants of its own
- K171886: OverStitch SX Endoscopic Suturing System (ESS) (2017), 7 descendants of its own

## Indications for use
For endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for approximation of tissue for the treatment of symptomatic Gastroesophageal Reflux Disease.

Source page: https://510kreport.com/device/K003956
Methodology: https://510kreport.com/methodology