DeviceClearance

Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more— 510(k) K260580

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K260580 for Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more, Substantially Equivalent on 2026-05-21. Applicant: Olympus Medical Systems Corp.. Device class: 2.

Summary

Olympus Medical Systems' record covers a Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) and four clip types: Clip, Long Clip, Short Clip and Super Short Clip, each with its own model numbers. The product code is PKL, hemostatic metal clips for the GI tract.

Class II, 21 CFR 876.4400. Gastroenterology and Urology is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Olympus filed from Hachioji-Shi, Japan. The decision came 90 calendar days after receipt (February 20 to May 21, 2026).

Clearance details

Device name as filed
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)
Applicant
Olympus Medical Systems Corp.
Product code
Product code PKL
Device class
Class 2
Regulation
21 CFR 876.4400
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hachioji-Shi, JP
Download summary PDFView on FDA.gov ↗

Recent devices under product code PKL

view all

More clearances from Olympus Medical Systems Corp.

view all

Adverse events under product code PKL

product code PKL
Death
9
Injury
489
Malfunction
4,698
Other
1
Total
5,197

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.