OBSIDIO Conformable Embolic— 510(k) K261488

Name: FDA 510(k) clearance K261488
Creator: U.S. Food and Drug Administration
Published: 2026-07-24

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K261488 for OBSIDIO Conformable Embolic, Substantially Equivalent on 2026-07-24. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code KRD
Device class: Class 2
Regulation: 21 CFR 870.3300
Advisory panel: Cardiovascular
Date received: 2026-05-06
Decision date: 2026-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRD

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K261866 — Concerto Versa Detachable Coil2026-06-24
K260635 — HARBOR Occlusion Device2026-06-12
K260508 — LOBO Vascular Occlusion System2026-04-10
K253511 — Concerto Versa Detachable Coil2026-01-14
K253677 — Tembo Embolic System2025-12-15

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K260428 — RIVOS EUS Access Device (M00553900)2026-06-17
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Adverse events under product code KRD

product code KRD

Death: 119
Injury: 1,869
Malfunction: 7,015
Other: 1
Total: 9,004

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.