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 System, Ablation, Microwave And Accessories
510(k) Number K200298
Device Name ABI Instrument, Creo Electrosurgical System
Applicant
Creo Medical, Ltd.
Creo House, Unit 2, Beaufort Park Way
Chepstow,  GB NP16 5UH
Applicant Contact Patrick Burn
Correspondent
Phil Triolo and Associates LC
86 Skycrest Ln
Salt Lake City,  UT  84108
Correspondent Contact Phil Triolo
Regulation Number878.4400
Classification Product Code
NEY  
Date Received02/06/2020
Decision Date 01/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-