FDA 510(k)

Sphincterotome / short-wire compatible, Sterile Sphincterotome

K-Number: K210934 · 2021-12-01

Decision Date2021-12-01

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Sphincterotome / short-wire compatible, Sterile Sphincterotome is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-01 under 510(k) number K210934. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sphincterotome / short-wire compatible, Sterile Sphincterotome?

Sphincterotome / short-wire compatible, Sterile Sphincterotome is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K210934.

When did Sphincterotome / short-wire compatible, Sterile Sphincterotome receive FDA 510(k) clearance?

Sphincterotome / short-wire compatible, Sterile Sphincterotome received FDA 510(k) clearance on 2021-12-01, under 510(k) number K210934.

Who is the listed applicant for Sphincterotome / short-wire compatible, Sterile Sphincterotome?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sphincterotome / short-wire compatible, Sterile Sphincterotome?

The FDA product code for Sphincterotome / short-wire compatible, Sterile Sphincterotome is KNS.

Other records listing Micro-Tech (Nanjing) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252492Visualized Access and Delivery Catheter; PB Digital Controller K251692Advanced Tissue Resection Device K250229Dual Action Tissue Closure Device K243388Disposable Distal Cap K243471Extraction Basket K230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible

View all 37 devices →

Related Devices (Code: KNS)

K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single 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.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.