Cleared Special

OBSIDIO? Conformable Embolic (M0013972101010)

K253376 · Boston Scientific Corporation · Cardiovascular
Oct 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K253376 is an FDA 510(k) clearance for the OBSIDIO? Conformable Embolic (M0013972101010), a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on October 30, 2025, 30 days after receiving the submission on September 30, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K253376 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2025
Decision Date October 30, 2025
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRD — Device, Vascular, For Promoting Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3300

Similar Devices — KRD Device, Vascular, For Promoting Embolization

All 126
Concerto Versa? Detachable Coil
K253511 · Medtronic, Inc. · Jan 2026
Tembo Embolic System
K253677 · Instylla, Inc. · Dec 2025
Polyvinyl Alcohol Embolic Microspheres
K250209 · Canyon Medical, Inc. · Sep 2025
HARBOR Occlusion Device
K250133 · Nuvascular, Inc. · Jul 2025
Prestige Coil System (Prestige Packing Line Extension)
K251383 · Balt USA, LLC · May 2025
Embosphere Microspheres
K250971 · Biosphere Medical, S.A. · May 2025