Cleared Traditional

K251403 - Dornier Bi-Polar Electrode BIP12CLM Bip...

K251403 is an FDA 510(k) clearance for Dornier Bi-Polar Electrode BIP12CLM Bip..., manufactured by Dornier Medtech America Inc (Dmta). The device is a Class 2 Gastroenterology & Urology device with product code FAS cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K251403 · Dornier Medtech America Inc (Dmta) · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
213d
Days
Class 2
Risk

K251403 is an FDA 510(k) clearance for the Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr El.... Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Dornier Medtech America Inc (Dmta) (Kennesaw, US). The FDA issued a Cleared decision on December 5, 2025 after a review of 213 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dornier Medtech America Inc (Dmta) devices

FDA 510(k) Submission Details - K251403

510(k) Number K251403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2025
Decision Date December 05, 2025
Days to Decision 213 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 130d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAS Device Classification - Class 2, Special Controls

Product Code FAS Electrode, Electrosurgical, Active, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAS Electrode, Electrosurgical, Active, Urological

All 28
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