510(k) Report

510(k) · Cleared

Cleared

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 )

K251403510(k) TraditionalCleared Dec 5, 2025213-day reviewClass II21 CFR 876.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dornier Medtech America Inc (Dmta) · FAS Electrode, Electrosurgical, Active, Urological

Cleared on Dec 5, 2025 as substantially equivalent to K151976 (Omnitech Systems, Inc., 2016) after a 213-day review. Its family tree reaches back 1 generation to 2016.

Decided
Dec 5, 2025
Review
213 days
Class
Class II
Product code
FAS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K151976 (2016). No later device cites it as a predicate yet.

K151976 · Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode · Omnitech Systems, Inc. · 2016201620182020202220242026
K151976 · Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode · Omnitech Systems, Inc. · 20160
  1. Root · 1 generation backK151976 Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeOmnitech Systems, Inc. · 2016
  2. This deviceK251403 Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop…Dornier Medtech America Inc (Dmta) · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeOmnitech Systems, Inc.2016—
0 (this device)K251403Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr…Dornier Medtech America Inc (Dmta)2025—
FIG. 1 — Lineage of K251403, 2016–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FAS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FAS device

  1. #1 K250522 Multi4 Systemscore 11.4 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
Summary page 6
…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K151976 Omnitech HF Resection/Vaporization Electrode FAS Device…
Omnitech Systems, Inc.2016—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All FAS devices

FAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · FAS

2in 2025

2010: 32011: 12012: 22015: 12016: 12017: 22021: 22022: 12024: 12025: 2
2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FAS

150in 2010

2010: 150 days median
2007high 150 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FAS

1in 2023

2016: 22021: 42023: 1
2007high 4 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FAS

395in 2025

2007: 62008: 132009: 92010: 252011: 332012: 302013: 482014: 522015: 822016: 692017: 1212018: 702019: 612020: 1002021: 1022022: 1472023: 3292024: 3102025: 395
2007high 395 (2025) · low 6 (2007)2025

MAUDE reports naming product code FAS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—06
20080—013
20090—09
20103150025
20111—033
20122—030
20130—048
20140—052
20151—082
20161—269
20172—0121
20180—070
20190—061
20200—0100
20212—4102
20221—0147
20230—1329
20241—0310
20252—0395
20260—0—

What is it indicated for?

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…

Read the full statement (322 words)

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

Indications for use as stated in the FDA summary.

Recent decisions in FAS

The FAS category page

  • K250522Multi4 SystemMulti4 Medical AB · 2025
  • K240504PLASMA EDGE SystemLamidey Noury Medical · 2024
  • K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie Innovation · 2022
  • K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 20211 recall
  • K210394Electrosurgical accessoryDornier Medtech America, Inc. · 2021

https://510kreport.com/device/K251403 · printed Nov 6, 2026

Cite this page

510(k) Report. “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 ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251403

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026