Cleared Special

Tembo Embolic System

K253677 · Instylla, Inc. · Cardiovascular
Dec 2025
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K253677 is an FDA 510(k) clearance for the Tembo Embolic System, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Instylla, Inc. (Bedford, US). The FDA issued a Cleared decision on December 15, 2025, 24 days after receiving the submission on November 21, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K253677 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2025
Decision Date December 15, 2025
Days to Decision 24 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

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