510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250945Substantially Equivalent

Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)

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

K250945 is the FDA 510(k) clearance record for Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series), a class II device, cleared for Olympus Medical Systems Corp. on under FDA product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)). FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from to . As of , FDA records show 16 recalls naming K250945.

Clearance record

Decision date
Received
(203 days to decision)
Product code
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation
21 CFR 876.4300
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 KNS

Trailing 12 months
4 clearances under product code KNS in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KNS, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260