PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop
FDA 510(k) clearance K250844 · decided 2025-06-02
Clearance details
- K-number
- K250844
- Device name
- PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop
- Applicant
- Science & Bio Materials (S.B.M.) Sas
- Decision
- Substantially Equivalent
- Date received
- 2025-03-20
- Decision date
- 2025-06-02
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lourdes, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.