510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210638Substantially Equivalent

i-ED COIL System

Kaneka Medical America LLC, New York NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210638 is the FDA 510(k) clearance record for i-ED COIL System, a class II device, cleared for Kaneka Medical America, LLC on under FDA product code HCG (Device, Neurovascular Embolization). FDA records list 2 510(k) clearances for Kaneka Medical America, LLC, from to . As of , FDA records show no recalls naming K210638.

Clearance record

Decision date
Received
(23 days to decision)
Product code
HCG Device, Neurovascular Embolization
Regulation
21 CFR 882.5950
Device class
Class II
Review panel
Neurology
Applicant
Kaneka Medical America, LLC 623 Fifth Ave., New York NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HCG

Trailing 12 months
5 clearances under product code HCG in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HCG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20260