FDA 510(k) Application Details - K230621

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

  More FDA Info for this Device
510(K) Number K230621
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Surgical Principals, Inc.
1625 South Tacoma Way
Tacoma, WA 98409 US
Other 510(k) Applications for this Company
Contact Timothy Wynne
Other 510(k) Applications for this Contact
Regulation Number 878.4400

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

  More FDA Info for this Product Code
Date Received 03/06/2023
Decision Date 12/01/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K230621


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