510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021397Substantially Equivalent

Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization

Biosphere Medical, S.A., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021397 is the FDA 510(k) clearance record for EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION, a class II device, cleared for Biosphere Medical, Inc. on under FDA product code NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids). FDA records list 18 510(k) clearances for Biosphere Medical, Inc., from to . As of , FDA records show no recalls naming K021397.

Clearance record

Decision date
Received
(204 days to decision)
Product code
NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
Regulation
21 CFR 870.3300
Device class
Class II
Review panel
Cardiovascular
Applicant
Biosphere Medical, Inc. 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NAJ

Trailing 12 months

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

FDA records show no clearances under product code NAJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NAJ, 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