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, Biopsy
510(k) Number K242029
Device Name TRAP EASY
Applicant
H.S Hospital Service S.P.A
Via Zosimo 13
Rome,  IT 00178
Applicant Contact Massimiliano Improta
Correspondent
Isemed S.R.L.
Via P. Togliatti, 19/X
Imola (Bo),  IT 40026
Correspondent Contact Guido Bonapace
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/11/2024
Decision Date 10/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-