510(k) K233302
K233302 is an FDA 510(k) premarket notification submitted by OSSIO , Ltd. for the device "OSSIOfiber® Compression Staple". The FDA issued a decision of Substantially Equivalent on November 16, 2023. The device falls under product code MNU (Staple, Absorbable), a Class II device regulated under 21 CFR 888.3030. OSSIO , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2023
- Date Received
- September 29, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Absorbable
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type