510(k) K152111

Symmetry Surgical Quad-Lock Container System by Symmetry Surgical, Inc. — Product Code KCT

K152111 is an FDA 510(k) premarket notification submitted by Symmetry Surgical, Inc. for the device "Symmetry Surgical Quad-Lock Container System". The FDA issued a decision of Substantially Equivalent on April 14, 2016. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Symmetry Surgical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2016
Date Received
July 29, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type