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 Endoscopic Grasping/Cutting Instrument, Non-Powered
510(k) Number K242923
Device Name SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)
Applicant
Envision Endoscopy
204 Second Ave., 2nd Floor
Waltham,  MA  02451
Applicant Contact Azadeh Khanicheh
Correspondent
Envision Endoscopy
204 Second Ave., 2nd Floor
Waltham,  MA  02451
Correspondent Contact Azadeh Khanicheh
Regulation Number876.1500
Classification Product Code
OCZ  
Date Received09/24/2024
Decision Date 12/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-