510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K193036Substantially Equivalent

C2 CryoBalloon EndoGrip

Pentax Medical, A Division of Pentax of America, Inc., Redwood, Ca CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193036 is the FDA 510(k) clearance record for C2 CryoBalloon EndoGrip, a class II device, cleared for Pentax Medical, A Division of Pentax of America, Inc. on under FDA product code OCX (Endoscopic Irrigation/Suction System). FDA's definition for product code OCX reads: "To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures". FDA records list 2 510(k) clearances for Pentax Medical, A Division of Pentax of America, Inc., from to . As of , FDA records show no recalls naming K193036.

Clearance record

Decision date
Received
(22 days to decision)
Product code
OCX Endoscopic Irrigation/Suction System
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pentax Medical, A Division of Pentax of America, Inc. 303 Convention Way, Suite 1, Redwood, Ca CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCX

Trailing 12 months

FDA records hold no clearances under product code OCX in the trailing twelve months.

FDA records show no clearances under product code OCX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260