C2 CryoBalloon EndoGrip

by Pentax Medical a Division of Pentax of America Inc United States 510(k)

510(k) K193036

Product code OCX

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK193036	Date22 Nov 2019Cleared	StatusActive

Coverage

1 jurisdiction

Active
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K193036
FDA Product Code: OCX
FDA applicant: Pentax Medical, A Division of Pentax of America, Inc.

Device Class: Class II
Regulation: 21 CFR Part 876.1500
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K193036 24 fields · synced 22 Oct 2026