K240617
- 510(k) number
- K240617
- Device name
- 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. JP
- Product code
- PKL — Hemostatic Metal Clip For The Gi Tract
- Decision date
- 2024-06-03
- Date received
- 2024-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 4.5 MB · U.S. public domain
Also available from FDA: K240617.pdf
Official FDA record: K240617
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.