510(k) K132472
K132472 is an FDA 510(k) premarket notification submitted by Justright Surgical, LLC for the device "JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD". The FDA issued a decision of Substantially Equivalent on February 11, 2014. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Justright Surgical, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2014
- Date Received
- August 7, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type