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, Cryosurgical, Accessories
510(k) Number K240457
Device Name C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
Applicant
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645
Applicant Contact Gurvinder Singh Nanda
Correspondent
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645
Correspondent Contact Gurvinder Singh Nanda
Regulation Number878.4350
Classification Product Code
GEH  
Date Received02/16/2024
Decision Date 07/24/2024
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
-
-