510(k) K223122
K223122 is an FDA 510(k) premarket notification submitted by S.B.M. Sas (Science & Bio Materials) for the device "MENIX®; MENIX® DUO". The FDA issued a decision of Substantially Equivalent on August 3, 2023. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. S.B.M. Sas (Science & Bio Materials) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 2023
- Date Received
- October 3, 2022
- 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