510(k) K242272

CORIOGRAPH Pre-Op Planning and Modeling Services by Blue Belt Technologies, Inc.

K242272 is an FDA 510(k) premarket notification submitted by Blue Belt Technologies, Inc. for the device "CORIOGRAPH Pre-Op Planning and Modeling Services". The FDA issued a decision of Substantially Equivalent on November 15, 2024. Blue Belt Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2024
Date Received
August 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No