About This 510(k) Submission
K251403 is an FDA 510(k) clearance for the Dornier Bi-Polar Electrode BIP12CLM Bipolar 12? Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12? Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30? Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30? Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ), a Electrode, Electrosurgical, Active, Urological (Class II — Special Controls, product code FAS), submitted by Dornier Medtech America Inc (Dmta) (Kennesaw, US). The FDA issued a Cleared decision on December 5, 2025, 213 days after receiving the submission on May 6, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.