# K931962: Non-Absorbable Gauze

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Dec 10, 1993 after 233 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- May 9, 2017 · Class II · Z-2622-2017: Cotton tip of the device may disengage due to insufficient adhesive

Source page: https://510kreport.com/device/K931962
Methodology: https://510kreport.com/methodology