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FDA 510(k) Application Details - K210631
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K210631
Device Name
Instrument, Biopsy
Applicant
Avitus Orthopaedics, Inc.
6 Amstrong Rd, Suite 107
Shelton, CT 06484 US
Other 510(k) Applications for this Company
Contact
Maxim Budyansky
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
KNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/03/2021
Decision Date
03/31/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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