# K903205: Auto Suture (R) Endoscopic Clamp

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Oct 11, 1990 after 83 days
- Product code: HDA (Forceps, Obstetrical)
- Device class: 2
- Regulation: 21 CFR 884.4400
- Recalls of this device: 3 (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
- Mar 13, 2019 · Class II · Z-1212-2019: Sterilization method used was not consistent with the labeling and the approved sterilization method
- Mar 13, 2019 · Class II · Z-1211-2019: Sterilization method used was not consistent with the labeling and the approved sterilization method
- Mar 13, 2019 · Class II · Z-1213-2019: Sterilization method used was not consistent with the labeling and the approved sterilization method

Source page: https://510kreport.com/device/K903205
Methodology: https://510kreport.com/methodology