# K091380: Cordcap

- Pathway: 510(k) (Traditional)
- Applicant: Centrix, Inc.
- Decided: Jul 30, 2009 after 80 days
- Product code: MVL (Cord, Retraction)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010070 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010070: Ultrapak Neha, Ultradent Products, Inc. (2001) Summary page 1.
- K041023: Stay-Put Impregnated, Coltene/Whaledent GmbH & Co. KG (2004) Summary page 1.

## Indications for use
CordCapTM is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means.

Source page: https://510kreport.com/device/K091380
Methodology: https://510kreport.com/methodology