510(k) K250844

PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop by Science & Bio Materials (S.B.M.) Sas — Product Code MBI

K250844 is an FDA 510(k) premarket notification submitted by Science & Bio Materials (S.B.M.) Sas for the device "PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop". The FDA issued a decision of Substantially Equivalent on June 2, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Science & Bio Materials (S.B.M.) Sas has at least 1 other 510(k) clearance on record.