510(k) K180937
K180937 is an FDA 510(k) premarket notification submitted by SurGenTec, LLC for the device "Graftgun Universal Graft Delivery System". The FDA issued a decision of Substantially Equivalent on May 10, 2018. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. SurGenTec, LLC has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2018
- Date Received
- Apr 10, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)