510(k) K180191
K180191 is an FDA 510(k) premarket notification submitted by Arcuro Medical , Ltd. for the device "SuperBall Meniscal Repair System". The FDA issued a decision of Substantially Equivalent on June 5, 2018. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Arcuro Medical , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2018
- Date Received
- January 23, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type