510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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DEN160040Unknown

Embosphere Microspheres

Biosphere Medical, S.A., 383 Rue De La Belle Etoile, FR / Direct, Unknown
FDA source (opens on fda.gov)

DEN160040 is the FDA 510(k) clearance record for Embosphere Microspheres, a class II device, cleared for Biosphere Medical, S.A. on under FDA product code NOY (Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia). FDA's definition for product code NOY reads: "The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH)". FDA records list 18 510(k) clearances for Biosphere Medical, S.A., from to . As of , FDA records show no recalls naming DEN160040.

Clearance record

Decision date
Received
(320 days to decision)
Product code
NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Regulation
21 CFR 876.5550
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Biosphere Medical, S.A. A Wholly Owned Subsidiary Of Merit Medical Systems Inc., 383 Rue De La Belle Etoile, FR
Third party review
No

Clearances, product code NOY

Trailing 12 months

FDA records hold no clearances under product code NOY in the trailing twelve months.

FDA records show no clearances under product code NOY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NOY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260