# K011016: Lsi Solutions Flexible Suture Placement Device and Accessories Product

- Pathway: 510(k) (Special)
- Applicant: Lsi Solutions
- Decided: Apr 27, 2001 after 23 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
43 later devices descend from it; 7 cite it directly.
0 of 44 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
- 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

## Recalls of this device
- Apr 1, 2005 · Not classified · Z-0698-05: The expiration date listed on the product label is greater than the vendor recommended expiration date.

Source page: https://510kreport.com/device/K011016
Methodology: https://510kreport.com/methodology