FDA 510(k) Application Details - K173495

Device Classification Name

  More FDA Info for this Device
510(K) Number K173495
Device Name Single Use Hot Biopsy Forceps FD-231
Applicant Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-Shi 192-8507 JP
Other 510(k) Applications for this Company
Contact Toshiyuki Nakajima
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 11/13/2017
Decision Date 11/30/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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