# K073671: Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Ndo Surgical, Inc.
- Decided: Mar 26, 2008 after 90 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- 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
Longest line of descent: 5 generations back to K972679 (1997). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071553: Endoscopic Plication System; Eps; Plicator, Ndo Surgical, Inc. (2007). Our OCR of the scanned summary read K071533, FDA’s number for Fitmate Series (Cosmed Srl). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NDQ Surgical Plicator™ Endoscopic Plication System”.
- K072125: Endoscopic Plication System, Eps, Eplicator, Plicator Instrument, Ndo Surgical, Inc. (2007) Summary page 4.
- K994290: Bard Endoscopic Suturing System, C.R. Bard, Inc. (2000) Summary page 4.
- K003956: Bard Endocinch Suturing System # 000452; 000454; 000595, C.R. Bard, Inc. (2001) Summary page 4.
- K062875: Endogastric Stomaphyx Device and Accessories, Endogastric Solutions, Inc. (2007) Summary page 4.
- K070151: Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier, Ethicon Endo-Surgery, LLC (2007) Summary page 4.
- K023234: Endoscopic Plication System, Ndo Surgical, Inc. (2003) Summary page 5.
- K032820: Modification to Endoscopic Plication System, Ndo Surgical, Inc. (2003) Summary page 5.

## Most influential descendants
- K082044: Ace Stapler, Model F0031 (2010), 2 descendants of its own
- K110829: Ace Stapler and Cartridge (2011), 1 descendant of its own
- K120147: Ace Stapler and Cartridge (2012), 0 descendants of its own

## Indications for use
The Plicator GSX™ Suturing System is indicated for the endoscopic placement of sutures to approximate and fixate gastrointestinal soft tissue.

Source page: https://510kreport.com/device/K073671
Methodology: https://510kreport.com/methodology