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
SUBSCRIBE / SIGN IN
K100663Substantially Equivalent

Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321

Boston Scientific Corporation, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100663 is the FDA 510(k) clearance record for CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321, a class II device, cleared for Boston Scientific Corporation on under FDA product code NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K100663.

Clearance record

Decision date
Received
(39 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
Boston Scientific Corporation One Scimed Pl., Maple Grove MN
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