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FDA 510(k) Application Details - K202659
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K202659
Device Name
Arthroscope
Applicant
Stryker
5900 Optical Court
San Jose, CA 95138 US
Other 510(k) Applications for this Company
Contact
Christie Samsa
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/2020
Decision Date
12/01/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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