FDA 510(k) Application Details - K220656

Device Classification Name Device, Surgical, Cryogenic

  More FDA Info for this Device
510(K) Number K220656
Device Name Device, Surgical, Cryogenic
Applicant Pacira Biosciences, Inc.
10450 Science Center Drive
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact Danny Rivera
Other 510(k) Applications for this Contact
Regulation Number 882.4250

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

  More FDA Info for this Product Code
Date Received 03/07/2022
Decision Date 05/20/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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