510(k) K131637
K131637 is an FDA 510(k) premarket notification submitted by Rotation Medical, Inc. for the device "ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)". The FDA issued a decision of Substantially Equivalent on July 12, 2013. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Rotation Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2013
- Date Received
- June 4, 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