510(k) K231885
K231885 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "Medline UNITE® REFLEX® Nitinol Staple System". The FDA issued a decision of Substantially Equivalent on August 9, 2023. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Medline Industries, LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 2023
- Date Received
- June 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type