# K070151: Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Aug 15, 2007 after 211 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: 4 generations back to K972679 (1997). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003956: Bard Endocinch Suturing System # 000452; 000454; 000595, C.R. Bard, Inc. (2001) Summary page 1.
- K011016: Lsi Solutions Flexible Suture Placement Device and Accessories Product, Lsi Solutions (2001)
- K061770: Ethicon Endo Surgery Endoscopic Suturing System, Ethicon Endo-Surgery, Inc. (2006) Summary page 1.
- K062875: Endogastric Stomaphyx Device and Accessories, Endogastric Solutions, Inc. (2007). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K073671: Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture Cartridge (2008), 3 descendants of its own
- 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 Tissue Apposition System (TAS) is indicated for endoscopic placement of suture(s) and approximation of soft tissue.

Source page: https://510kreport.com/device/K070151
Methodology: https://510kreport.com/methodology