Cleared Traditional

TEMBO Embolic System

K240873 · Instylla, Inc. · Cardiovascular
Dec 2024
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K240873 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 16, 2024, 262 days after receiving the submission on March 29, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K240873 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2024
Decision Date December 16, 2024
Days to Decision 262 days
Submission Type Traditional
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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