Cleared Traditional

K240617 - Single Use Reloadable Clip Applicator (...

Also marketed or referenced as:
Clip (HX-610-090, HX-610-135) Long Clip (HX-610-090L, HX-610-135L) Short Clip (HX-610-090S, HX-610-135S) Super Short Clip (HX-610-135XS)

K240617 is the FDA 510(k) clearance for Single Use Reloadable Clip Applicator (... by Olympus Medical Systems Corp.. It is a Class 2 Gastroenterology & Urology device (product code PKL) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K240617 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
90d
Days
Class 2
Risk

K240617 is an FDA 510(k) clearance for the Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR). Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on June 3, 2024 after a review of 90 days - within the typical 510(k) review window.

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. 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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K240617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2024
Decision Date June 03, 2024
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Olympus Corporation of the Americas
Rebecca Walker

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 54
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K240617.
BARS Set (100.60)
K241858 · Ovesco Endoscopy AG · Aug 2024
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K232969 · Ningbo Xinwell Medical Technology Co., Ltd. · Jun 2024
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K233772 · Mirco-Tech (Nanjing) Co., Ltd. · Mar 2024
Disposable Hemostatic Clips
K232450 · Zhejiang Soudon Medical Technology Co., Ltd. · Jan 2024
Disposable Hemoclip (AF series)
K231633 · Alton (Shanghai) Medical Instruments Co., Ltd. · Jan 2024