510(k) K172405

SNIPER STAPLE SYSTEM, NON-STERILE by Trilliant Surgical — Product Code JDR

K172405 is an FDA 510(k) premarket notification submitted by Trilliant Surgical for the device "SNIPER STAPLE SYSTEM, NON-STERILE". The FDA issued a decision of Substantially Equivalent on December 11, 2017. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Trilliant Surgical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2017
Date Received
August 9, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type