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 hysteroscope (and accessories)
510(k) Number K982771
Device Name GYRUS HYSTEROSCOPIC RESECTOSCOPE
Applicant
GYRUS MEDICAL LTD.
FORTRAN RD., ST. MELLONS
CARDIFF,  GB CF3 0LT
Applicant Contact DAVID KAY
Correspondent
GYRUS MEDICAL LTD.
FORTRAN RD., ST. MELLONS
CARDIFF,  GB CF3 0LT
Correspondent Contact DAVID KAY
Regulation Number884.1690
Classification Product Code
HIH  
Date Received08/07/1998
Decision Date 01/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-