# K961771: Auto Suture Surgiwand

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Sep 25, 1996 after 140 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903207 (1990). 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)
- K903207: Auto Suture Endoscopic Suction/Irrigatrion Device, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.

## Recalls of this device
- Mar 5, 2021 · Class II · Z-1411-2021: Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which co

## Indications for use
the subject device is only indicated for open and thoracoscopic surgery (non-insufflated).

Source page: https://510kreport.com/device/K961771
Methodology: https://510kreport.com/methodology