• 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 Electrode, Electrosurgical, Active, Urological
510(k) Number K933175
Device Name GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE
Applicant
GREENWALD SURGICAL CO., INC.
2688 DEKALB ST.
LAKE STATION,  IN  46405
Applicant Contact CHRISTOPHER REYNOLDS
Correspondent
GREENWALD SURGICAL CO., INC.
2688 DEKALB ST.
LAKE STATION,  IN  46405
Correspondent Contact CHRISTOPHER REYNOLDS
Regulation Number876.4300
Classification Product Code
FAS  
Date Received06/29/1993
Decision Date 04/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-