Cleared Traditional

K261488 - OBSIDIO Conformable Embolic

K261488 is the FDA 510(k) clearance for OBSIDIO Conformable Embolic by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K261488 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
79d
Days
Class 2
Risk

K261488 is an FDA 510(k) clearance for the OBSIDIO Conformable Embolic. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on July 24, 2026 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K261488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2026
Decision Date July 24, 2026
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 97
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K261488.
Concerto Versa™ Detachable Coil
K261866 · Medtronic, Inc. · Jun 2026
LOBO Vascular Occlusion System
K260508 · Okami Medical, Inc. · Apr 2026
Concerto Versa™ Detachable Coil
K253511 · Medtronic, Inc. · Jan 2026
Tembo Embolic System
K253677 · Instylla, Inc. · Dec 2025
OBSIDIO™ Conformable Embolic (M0013972101010)
K253376 · Boston Scientific Corporation · Oct 2025
Polyvinyl Alcohol Embolic Microspheres
K250209 · Canyon Medical, Inc. · Sep 2025