510(k) K152111
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