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

TPLC - Total Product Life Cycle
  • 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 show TPLC since Back to Search Results
Device powered insertion system for a cochlear implant electrode array
Regulation Description Powered insertion system for a cochlear implant electrode array.
Definition A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea.
Product CodeQQH
Regulation Number 874.4450
Device Class 2


Premarket Reviews
ManufacturerDecision
IOTAMOTION, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 3 3
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Iotamotion Inc III Nov-01-2024
-
-