FDA 510(k) Application Details - K243020

Device Classification Name Arthroscope

  More FDA Info for this Device
510(K) Number K243020
Device Name Arthroscope
Applicant IntraVu, Inc.
610 Price Ave
Redwood City, CA 94063 US
Other 510(k) Applications for this Company
Contact Jenna Rapoport
Other 510(k) Applications for this Contact
Regulation Number 888.1100

  More FDA Info for this Regulation Number
Classification Product Code HRX
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 09/27/2024
Decision Date 12/02/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K243020


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact