RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612— 510(k) K122660

Name: FDA 510(k) clearance K122660
Creator: U.S. Food and Drug Administration
Published: 2012-12-03

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K122660 for RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612, Substantially Equivalent on 2012-12-03. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code PKL
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2012-08-31
Decision date: 2012-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PKL

view all

K254069 — Hemoclip (511 series, 543 series)2026-08-10
K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more2026-05-21
K252270 — Hemoclip2026-04-08
K253734 — Taurus Clip2026-03-12
K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n)2025-12-18

More clearances from Boston Scientific Corporation

view all

K262151 — SpaceOAR Flex System2026-09-11
K261153 — LithoVue Elite Digital Flexible Ureteroscope System2026-08-26
K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
K261488 — OBSIDIO Conformable Embolic2026-07-24
K262165 — FARADRIVE Steerable Sheath (M004PF21M402)2026-07-24

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, 2020-01-01 through 2026-04-23. 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.