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, electrosurgical, endoscopic (with or without accessories)
510(k) Number K942301
Device Name MICROVASIVE INJECTION GOLD PROBE
Applicant
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN,  MA  02472 -2407
Applicant Contact SHERI D O'BRIEN
Correspondent
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN,  MA  02472 -2407
Correspondent Contact SHERI D O'BRIEN
Regulation Number876.4300
Classification Product Code
KNS  
Date Received05/12/1994
Decision Date 11/02/1994
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
-
-