FDA 510(k) Application Details - K243639

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K243639
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	Grumpy Innovation, Inc. 2601 S Minnesota Ave Ste 105 Sioux Falls, SD 57105-4750 US Other 510(k) Applications for this Company
Contact	Sam Sharma Other 510(k) Applications for this Contact
Regulation Number	874.4760   More FDA Info for this Regulation Number
Classification Product Code	EOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2024
Decision Date	06/05/2025
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