Cleared Traditional

K253481 - colonic FTRD Set (200.70)

Also marketed or referenced as:
diagnostic FTRD Set (200.76) gastroduodenal FTRD Set (200.72)

K253481 is an FDA 510(k) clearance for colonic FTRD Set (200.70), manufactured by Ovesco Endoscopy AG. The device is a Class 2 Gastroenterology & Urology device with product code PKL cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K253481 · Ovesco Endoscopy AG · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
335d
Days
Class 2
Risk

K253481 is an FDA 510(k) clearance for the colonic FTRD Set (200.70). Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Ovesco Endoscopy AG (Tuebingen, DE). The FDA issued a Cleared decision on September 14, 2026 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - 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. Elevated predicate reliance profile. 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 Ovesco Endoscopy AG devices

FDA 510(k) Submission Details - K253481

510(k) Number K253481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2025
Decision Date September 14, 2026
Days to Decision 335 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
204d slower than avg
Panel avg: 131d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PKL Device Classification - Class 2, Special Controls

Product Code PKL Hemostatic Metal Clip For The Gi Tract
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
Definition Clip Placement Within The Gastrointestinal (gi) Tract For The Purpose Of Endoscopic Marking, Hemostasis For Mucosal/sub-mucosal Defects, Bleeding Ulcers, Arteries, Polyps, Diverticula In The Colon, Prophylactic Clipping, Anchoring Feeding Tubes, Supplemental Closure Method Of Luminal Perforations.
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 Consultant

Novineon CRO GmbH
Maria Kiel

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PKL Hemostatic Metal Clip For The Gi Tract

All 66
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K253481.
stentFIX System Set (100.50n)
K260487 · Ovesco Endoscopy AG · Oct 2026
Hemostatic Clip
K261741 · Anrei Medical (Hz) Co., Ltd. · Oct 2026
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K254069 · Hangzhou AGS MedTech Co., Ltd. · Aug 2026
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)
K260580 · Olympus Medical Systems Corp. · May 2026
Hemoclip
K252270 · Hangzhou AGS MedTech Co., Ltd. · Apr 2026
Taurus Clip
K253734 · Taurus Endoscopy · Mar 2026