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 Instrument, Ultrasonic Surgical
510(k) Number K212614
Device Name Ultrasonic Scalpel System
Applicant
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
#1 Xinxingyilu Rd., Emerging Industrial Cluster Area
Zonghan Subdistrict
Cixi,  CN 315301
Applicant Contact Guofang Ma
Correspondent
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
#1 Xinxingyilu Rd., Emerging Industrial Cluster Area
Zonghan Subdistrict
Cixi,  CN 315301
Correspondent Contact Guofang Ma
Classification Product Code
LFL  
Date Received08/18/2021
Decision Date 07/18/2022
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-