PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop— 510(k) K250844

Substantially Equivalent

Science & Bio Materials (S.B.M.) Sas

FDA 510(k) clearance K250844 for PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop, Substantially Equivalent on 2025-06-02. Applicant: Science & Bio Materials (S.B.M.) Sas.

Clearance details

Applicant: Science & Bio Materials (S.B.M.) Sas
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2025-03-20
Decision date: 2025-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lourdes, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.