Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K192342
Device Name Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
Applicant
Hangzhou AGS MedTech Co., Ltd.
Bldg. 5,Bldg. 6, #597 Kangxin Rd. Yuhang District
Hangzhou,  CN 311106
Applicant Contact Chunqi Han
Correspondent
Hangzhou AGS MedTech Co., Ltd.
Bldg. 5,Bldg. 6, #597 Kangxin Rd. Yuhang District
Hangzhou,  CN 311106
Correspondent Contact Chunqi Han
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Codes
FDI   GEI  
Date Received08/28/2019
Decision Date 05/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-