# K932553: Disposable Suture Placement System

- Pathway: 510(k) (Traditional)
- Applicant: Laurus Medical Corp.
- Decided: May 12, 1994 after 351 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K971797: Laparoscopic Bladder Neck Suspension Kit (1997), 5 descendants of its own
- K011190: Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System) (2002), 3 descendants of its own
- K020126: Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx TV System) (2002), 2 descendants of its own
- K020952: Surx RF System (2002), 1 descendant of its own
- K971791: Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension (1997), 1 descendant of its own

## Recalls of this device
- Feb 12, 2018 · Class II · Z-1620-2018: Potential for Capio sutures to break and /or detach.
- Feb 12, 2018 · Class II · Z-1618-2018: Potential for Capio sutures to break and /or detach.

Source page: https://510kreport.com/device/K932553
Methodology: https://510kreport.com/methodology