Name: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; 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.
Creator: FDA
Published: 2026-02-11T00:00:00+00:00
Keywords: Class II

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[Enforcement] Olympus Corporation of the Americas — Product Name: Single Use 3-Lumen Sp...

Feb 11, 2026

Published: 2026-02-11Captured: 2026-02-20Olympus Corporation of the AmericasProduct: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Description: These instruments have been designed to be us...

FDA issued a Class II enforcement action. Affects Olympus Corporation of the Americas. Reason: Devices which did not undergo thermoforming could deform and lose performance..

•Classification: Class II
•Firm: Olympus Corporation of the Americas
•Status: Ongoing
•Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, G...

Reason:Devices which did not undergo thermoforming could deform and lose performance.

Status:Ongoing

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR,...

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