FDA cleared 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 ) from Dornier Medtech America Inc (Dmta) on Dec 5, 2025 under K251403, a traditional 510(k). The device falls under product code FAS, Electrode, Electrosurgical, Active, Urological, regulated at 21 CFR 876.4300 as a Class 2 device. The review panel was Gastroenterology, Urology.
FDA logged the submission as received on May 6, 2025. The decision came 213 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Dornier Medtech America Inc (Dmta) in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K251403?
K251403 is the FDA 510(k) for 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 ), submitted by Dornier Medtech America Inc (Dmta). FDA's decision date was Dec 5, 2025, under product code FAS (Electrode, Electrosurgical, Active, Urological).
Who makes 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 )?
Dornier Medtech America Inc (Dmta), based in Kennesaw, GA, is the applicant of record for K251403.
How long did the K251403 review take?
FDA received the submission on May 6, 2025 and issued its decision on Dec 5, 2025, 213 days later.