FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

Polypectomy Snare

K Number: K172729 · Decision May 21, 2018
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
62
Applicant Total
17
Review Days
252

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Basic Information

Device Name
Polypectomy Snare
K Number
K172729
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.4300
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Hangzhou AGS MedTech Co., Ltd.
Date Received
September 11, 2017
Decision Date
May 21, 2018
Product Code
FDI
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FDI Snare, Flexible

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Other Clearances by Hangzhou AGS MedTech Co., Ltd.

K Number Device Name
K252270 Hemoclip
K252271 Hemoclip
K241704 Endoscopic Water Pump
K222421 Sphincterotome
K221713 Polypectomy Snare
K213143 Hemoclip
K213578 Balloon Dilatation Catheter
K211787 Hemoclip
K210406 Bipolar Coagulation Foreceps
K201121 Sphincterotome
Search all 17 clearances from Hangzhou AGS MedTech Co., Ltd. →