# K934738: Autosuture Endoscopic Suturing Device

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Mar 16, 1994 after 166 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
78 later devices descend from it; 4 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K082659: Modified Endo Stich (2008), 50 descendants of its own
- K090419: Sils Stitch Endoscopic Suturing Device (2009), 47 descendants of its own
- K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology (2010), 45 descendants of its own
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers (2011), 44 descendants of its own
- K994290: Bard Endoscopic Suturing System (2000), 23 descendants of its own

## Recalls of this device
- Apr 15, 2026 · Class II · Z-2281-2026: The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
- May 3, 2017 · Class II · Z-2543-2017: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

Source page: https://510kreport.com/device/K934738
Methodology: https://510kreport.com/methodology