510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K971125Substantially Equivalent

Endo Smartcap (100501)

Endo Smart Cap Co., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971125 is the FDA 510(k) clearance record for ENDO SMARTCAP (100501), a class II device, cleared for Endo Smart Cap Co. 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 one 510(k) clearance for Endo Smart Cap Co. As of , FDA records show no recalls naming K971125.

Clearance record

Decision date
Received
(57 days to decision)
Product code
OCX Endoscopic Irrigation/Suction System
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Endo Smart Cap Co. 16800 Imperial Valley Dr.,, Houston TX
510(k) summary
Summary
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