Cleared Traditional

Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); 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 · Olympus Medical Systems Corp. · Gastroenterology & Urology

Jun 2024

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K240617 is an FDA 510(k) clearance for the Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); 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), a Hemostatic Metal Clip For The Gi Tract (Class II — Special Controls, product code PKL), submitted by Olympus Medical Systems Corp. (Hachiochi-Shi, JP). The FDA issued a Cleared decision on June 3, 2024, 90 days after receiving the submission on March 5, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.

Submission Details

510(k) Number	K240617 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PKL — Hemostatic Metal Clip For The Gi Tract
Device Class	Class II — 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.