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Disposable Sphincterotome

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242192

by Beijing ZKSK Technology Co., Ltd

Identifiers

510(k) Number
K242192 FDA 510(k)
FDA Product Code
KNS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4300 FDA 510(k)
Regulation Number
876.4300 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Disposable Sphincterotome is an endoscopic electrosurgical device designed for cutting and incising tissue, specifically within the biliary or pancreatic ducts. It is intended for use in procedures requiring precise sphincterotomy, such as the removal of gallstones or biliary strictures, where controlled incision of the sphincter of Oddi is necessary.

This single-use device is supplied sterile and intended for use in clinical settings such as gastroenterology and urology. It is classified as a Class 2 medical device under FDA regulation 21 CFR 876.4300 and has received FDA 510(k) clearance (K242192) through the Traditional 510(k) pathway. The device is non-reusable and must be disposed of after a single procedure.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K242192 - Disposable Sphincterotome | FDA 510 (k), Beijing Zksk Technology Co., Ltd. FDA 510 (k) Products, Disposable Sphincterotome (K242192) — FDA 510(k) | Innolitics, AccessGUDID - DEVICE: ZKSK (06934415024631)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Beijing ZKSK Technology Co., Ltd
FDA Applicant
Beijing Zksk Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K242192 24 fields · synced Oct 6, 2026