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 Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K221042
Device Name Renova RP Centesis Pump
Applicant
Gi Supply, Inc.
5069 Ritter Rd. Suite 104
Mechanicsburg,  PA  17055
Applicant Contact Erika Parry
Correspondent
Gi Supply, Inc.
5069 Ritter Rd. Suite 104
Mechanicsburg,  PA  17055
Correspondent Contact Thomas Saladin
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/08/2022
Decision Date 04/19/2023
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
-
-