510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250573Substantially Equivalent

Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M

Olympus Medical Systems Corp., Hachioji-Shi, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250573 is the FDA 510(k) clearance record for Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M, a class II device, cleared for Olympus Medical Systems Corp. on under FDA product code ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula). FDA's definition for product code ODD reads: "To identify stones, tumors, or narrowing in the biliary tree". FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from to . As of , FDA records show no recalls naming K250573.

Clearance record

Decision date
Received
(90 days to decision)
Product code
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODD

Trailing 12 months

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

FDA records show no clearances under product code ODD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ODD, 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