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