510(k) K251134
K251134 is an FDA 510(k) premarket notification submitted by TriMed, Inc. for the device "RipCord". The FDA issued a decision of Substantially Equivalent on July 11, 2025. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. TriMed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2025
- Date Received
- April 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Bolt Nut
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type