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 Arthroscope
510(k) Number K223244
Device Name Pristine Arthroscopic Visualization System
Applicant
Pristine Surgical
Brady Sullivan Tower, 6th Floor, 1750 Elm St.
Manchester,  NH  03104
Applicant Contact Stewart B Davis
Correspondent
Pristine Surgical
Brady Sullivan Tower, 6th Floor, 1750 Elm St.
Manchester,  NH  03104
Correspondent Contact Stewart B Davis
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/20/2022
Decision Date 12/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-