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

FDA 510(k)

UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION

K-Number: K103611 · 2011-05-09

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2011-05-09
Product CodeFDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2011-05-09 under 510(k) number K103611. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION?

UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION is a medical device that received FDA 510(k) clearance on 2011-05-09. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K103611.

When did UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION receive FDA 510(k) clearance?

UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION received FDA 510(k) clearance on 2011-05-09, under 510(k) number K103611.

Who is the listed applicant for UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION?

The FDA product code for UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION is FDI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing United States Endoscopy Group, Inc. 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.

K192265gi-4000 Electrosurgical GeneratorK200745Lariat, Hot/Cold SnareK192059Bio Guard Air/Water & Suction ValvesK191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMK182909Roth Net Retriever Product LineK182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm

View all 85 devices →

Related Devices (Code: FDI)

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.

K251692Advanced Tissue Resection DeviceMicro-Tech (Nanjing) Co., Ltd.K221713Polypectomy SnareHangzhou AGS MedTech Co., Ltd.K220846CORE-SNAREIncore Co., Ltd.K220089Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co., Ltd.K220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareYangzhou Fartley Medical Instrument Technology Co., Ltd.K213222Disposable Polypectomy SnareBeijing Zksk Technology Co., 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.

↑