FDA 510(k) Application Details - K212774

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K212774
Device Name	Instrument, Ent Manual Surgical
Applicant	Intersect ENT 1555 Adams Dr. Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Yoko Enrile Other 510(k) Applications for this Contact
Regulation Number	874.4420   More FDA Info for this Regulation Number
Classification Product Code	LRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2021
Decision Date	02/04/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review