510(k) K162365
K162365 is an FDA 510(k) premarket notification submitted by Terumobct, Inc. for the device "T-Cuff". The FDA issued a decision of Substantially Equivalent on February 16, 2017. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Terumobct, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2017
- Date Received
- August 23, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tourniquet, Pneumatic
- Device Class
- Class I
- Regulation Number
- 878.5910
- Review Panel
- SU
- Submission Type