# K193036: C2 CryoBalloon EndoGrip

- Pathway: 510(k) (Special)
- Applicant: Pentax Medical, A Division of Pentax of America, Inc.
- Decided: Nov 22, 2019 after 22 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K111821 (2011). 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)
- K152140: Boa Endoscopic Valve, C2 Therapeutics, Inc. (2015) Summary page 4.

## Indications for use
The C2 CryoBalloon™ EndoGrip is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.

Source page: https://510kreport.com/device/K193036
Methodology: https://510kreport.com/methodology