Cleared Traditional

Torpedo Gelatin Foam

K192480 · Biosphere Medical, S.A. · Cardiovascular
Nov 2019
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K192480 is an FDA 510(k) clearance for the Torpedo Gelatin Foam, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by Biosphere Medical, S.A. (Roissy-En-France, FR). The FDA issued a Cleared decision on November 21, 2019, 72 days after receiving the submission on September 10, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K192480 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2019
Decision Date November 21, 2019
Days to Decision 72 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

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
OBSIDIO? Conformable Embolic (M0013972101010)
K253376 · Boston Scientific Corporation · Oct 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