Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215— 510(k) K160241

Clearance details

Applicant

Olympus Medical Systems Corp.

Product code

Code KNS

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

2016-02-01

Decision date

2016-03-02

Decision

Substantially Equivalent

Clearance type

Special

Location

Hachioji-Shi, JP

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Death

44

Injury

2,361

Malfunction

4,771

Total

7,176

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1282-2026 — Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.Class II·Ongoing·Olympus Corporation of the Americas·20260107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160241.