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FDA 510(k) Application Details - K212656
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K212656
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
KARL STORZ Endoscopy America
2151 E. Grand Avenue
El Segundo, CA 90245 US
Other 510(k) Applications for this Company
Contact
Mario Trujillo
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
EOQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/23/2021
Decision Date
12/29/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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