# K971277: Safe-T-Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Talon Medical, Ltd.
- Decided: May 20, 1997 after 43 days
- Product code: KNA (Instrument, Manual, Specialized Obstetric-Gynecologic)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Indications for Use of the Safe-T-Clamp ™ are to simultaneously clamp and cut the umbilical cord

Source page: https://510kreport.com/device/K971277
Methodology: https://510kreport.com/methodology