# K972911: Auto Suture*Endostitch* II** Suture Applier

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Apr 25, 1998 after 261 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K961173: 1.2MM Reusable Neuroview Endoscope, Neuro Navigational Corp. (1996). Our OCR of the scanned summary read K961173, FDA’s number for 1.2MM Reusable Neuroview Endoscope (Neuro Navigational Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Modified Endoscopic Suturing device”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K061386: Anchor Band Suturing System, Model SR-AB (2006), 11 descendants of its own
- K062307: Xclose Tissue Repair System, Model SRS (2006), 9 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
- K100572: Versaclose, Model VC-200-01 (2010), 7 descendants of its own

## Indications for use
The Auto Suture* SurgiStitch** suture passer is indicated for the placement of interrupted sutures for soft tissue approximation in surgical procedures such as cardiovascular and gastrointestinal surgery.

Source page: https://510kreport.com/device/K972911
Methodology: https://510kreport.com/methodology