# K251403: 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 )

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America Inc (Dmta)
- Decided: Dec 5, 2025 after 213 days
- Product code: FAS (Electrode, Electrosurgical, Active, Urological)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K151976 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151976: Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode, Omnitech Systems, Inc. (2016) Summary page 6.

## Indications for use
INDICATIONS FOR USE AS A RESECTION ELECTRODE: The Dornier Bi Polar Electrode is designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation, or removal of soft tissue and where hemostasis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedure for which the devices can be used are: Transurethral resection in saline (TURis), Transurethral prostatectomy, transurethral resection of the prostate (TURP), for benign prostatic hyperplasia, Transurethral incision of the prostate (TUIP) or bladder neck, Transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate. The following electrodes are intended to be used as resection electrodes: BIP12CLL: BIPOLAR 12' Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLM: BIPOLAR 12' Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL: BIPOLAR 30' Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM: BIPOLAR 30' Medium 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 INDICATIONS FOR USE AS A VAPORIZATION ELECTRODE: The Dornier Bi Polar Electrode is designed and intended for use in urological surgical procedures involving vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indication include: Use in the prostate, bladder, and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH), bladder cancer, tumors, lesions and neoplasms. The specific urological indications include Transurethal Electro vaporization (TUVP), (TVP), (TUEVP) also known as Transurethal Vapor Resection of the prostate (TUVRP), Transurethal Vaporization in Saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate. The following electrode is intended to be used for plasma vaporization: BIPDDSC: BIPOLAR Dornier DiscTM 24 Fr Electrode-Sterile, Single-Use

Source page: https://510kreport.com/device/K251403
Methodology: https://510kreport.com/methodology