510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K120862Substantially Equivalent

Water Bottle Cap Irrigaton System

Boston Scientific Corporation, Alpharetta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120862 is the FDA 510(k) clearance record for WATER BOTTLE CAP IRRIGATON SYSTEM, a class II device, cleared for Endochoice, Inc. on under FDA product code FEQ (Pump, Air, Non-Manual, For Endoscope). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K120862.

Clearance record

Decision date
Received
(250 days to decision)
Product code
FEQ Pump, Air, Non-Manual, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Endochoice, Inc. 11810 Wills Rd., Alpharetta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FEQ

Trailing 12 months

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

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