Dornier Medtech America Inc (Dmta) · Class II · Cleared Dec 5, 2025
| K-number | K251403 |
| Device name | 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 ) |
| Applicant | Dornier Medtech America Inc (Dmta) |
| Product code | FAS |
| Device class | Class II |
| Decision date | Dec 5, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.4300 |
The Dornier Bi-Polar Electrode is a sterile, single-use bipolar electrosurgical electrode designed for endoscopic urological procedures. It delivers high-frequency electrical energy to resect, ablate, or vaporize soft tissue in the prostate, bladder, and bladder neck while providing hemostasis. The device is used with compatible resectoscopes and electrosurgical generators for procedures such as transurethral resection of the prostate (TURP) and transurethral resection of bladder tumors (TURBT).
The Dornier Bi-Polar Electrode has essentially the same technological characteristics, design, mechanical characteristics, and intended use as the predicate device. Both devices are single-use, sterilized with ethylene oxide (ETO), and designed to deliver controlled electrosurgical energy. The only significant difference is the use of tungsten versus platinum/iridium to form the loop and needle cutting surfaces.
ISO 10993-5:2009 (Cytotoxicity), ISO 10993-23:2021 (Irritation), ISO 10993-10:2021 (Sensitization), ISO 10993-11:2017 (Pyrogen and Systemic Toxicity), IEC 60601-1-2:2014, IEC 60601-1, and EN ISO 11135:2014 (ETO Sterilization). Testing also included dimensional analysis, mechanical characteristics (tensile strength), thermal penetration, electrical safety, and simulated use testing.
Substantial equivalence is established because the Dornier device has the same indications for use, same general design and function, and same technological characteristics as the predicate Omnitech HF Resection/Vaporization Electrode. Non-clinical bench testing demonstrated the device meets all predetermined acceptance criteria and performs equivalently to the predicate in dimensional, mechanical, thermal, and electrical safety parameters. Biocompatibility testing confirms components in contact with patients are biocompatible.
View the full FDA submission: accessdata.fda.gov