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
K192068Substantially Equivalent

i-ED COIL

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

K192068 is the FDA 510(k) clearance record for i-ED COIL, a class II device, cleared for Kaneka Pharma America, LLC on under FDA product code HCG (Device, Neurovascular Embolization). FDA records list 4 510(k) clearances for Kaneka Pharma America, LLC, from to . As of , FDA records show no recalls naming K192068.

Clearance record

Decision date
Received
(268 days to decision)
Product code
HCG Device, Neurovascular Embolization
Regulation
21 CFR 882.5950
Device class
Class II
Review panel
Neurology
Applicant
Kaneka Pharma America, LLC 546 Fifth Ave., 21st Floor, 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