Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sphincterotome / short-wire compatible, Sterile Sphincterotome

K-Number: K210934 · 2021-12-01

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2021-12-01
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

When was Sphincterotome / short-wire compatible, Sterile Sphincterotome approved by the FDA?

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

What company makes Sphincterotome / short-wire compatible, Sterile Sphincterotome?

Sphincterotome / short-wire compatible, Sterile Sphincterotome is manufactured by Micro-Tech (Nanjing) Co., Ltd..

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.

Related Clinical Trials

NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING

Other Devices by Micro-Tech (Nanjing) Co., Ltd.

K162466LuminScan (TM) Imaging System K160625Disposable Hot Biopsy Forceps K152802Grasping Forceps K172309Endoscopic Ultrasound Aspiration Needle K162226Reliant Multistage Dilatation Balloon Catheter K161463SureClip(TM) Repositionable Hemostasis Clip

View all 37 devices →

Related Devices (Code: KNS)

K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - LongSumitomo Bakelite Co., Ltd. K160417Rezum SystemNxthera, Inc. K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp. K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. K171993Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.

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.

↑