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

Humanitarian Device Exemption (HDE)
  • 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
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameFetoscopy Instruments Set
Classification Nameamnioscope, transabdominal (fetoscope) (and accessories)
Generic Nameamnioscope, transabdominal (fetoscope) (and accessories)
Regulation Number884.1600
Applicant
KARL STORZ Endoscopy-America, Inc.
2151 e. grand ave.
el segundo, CA 90245
HDE NumberH040005
Supplement NumberS006
Date Received07/09/2020
Decision Date02/22/2021
Product Code
HFA[ Registered Establishments with HFA ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
A change to the eyepiece of the miniature straight forward telescope, model #11630aa.
-
-