510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181021Substantially Equivalent

EmboCube Embolization Gelatin

Biosphere Medical, S.A., Roissy-En-France, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181021 is the FDA 510(k) clearance record for EmboCube Embolization Gelatin, a class II device, cleared for Biosphere Medical, S.A. on under FDA product code KRD (Device, Vascular, For Promoting Embolization). FDA records list 18 510(k) clearances for Biosphere Medical, S.A., from to . As of , FDA records show no recalls naming K181021.

Clearance record

Decision date
Received
(163 days to decision)
Product code
KRD Device, Vascular, For Promoting Embolization
Regulation
21 CFR 870.3300
Device class
Class II
Review panel
Cardiovascular
Applicant
Biosphere Medical, S.A. Parc Des Nations – Paris Nord 2, 383, Rue De La Belle Etoile, Roissy-En-France, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRD

Trailing 12 months
7 clearances under product code KRD in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20262
August 20260
September 20260
October 20260