# K964547: Degania Silicone Indenti Loops

- Pathway: 510(k) (Traditional)
- Applicant: Degania Silicone, Ltd.
- Decided: Jan 8, 1997 after 56 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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. The FDA summary names its predicate without a number.
- (no number) Degania Silicone Identi Loops: named in the summary without a submission number

## Indications for use
The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loop is not designed nor indicated for Implantation.

Source page: https://510kreport.com/device/K964547
Methodology: https://510kreport.com/methodology