# K983293: Auto Suture Laparoscopes Device

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Dec 16, 1998 after 86 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 1 generation back to K965055 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965055: Imagyn Microlap and Micro Lap-Gold Laparoscopes, Imagyn Medical, Inc. (1997) Summary page 1.

## Indications for use
The U.S. Surgical Auto Suture* Laparoscope** device has indication solely for illumination and visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic and thoracoscopic procedures.

Source page: https://510kreport.com/device/K983293
Methodology: https://510kreport.com/methodology