Skip to content

Disposable Hypodermic Needle Electrode, Model 9013S0421, 9013S0431, 9013S0441, 9013S0451, 9013S0461, 1013S0421, 103S0431

by Medtronic Functional Diagnostics A/S

510(k) K002992

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002992 Date15 Aug 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 10 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IKT
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 890.1385
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Other devices from Medtronic Functional Diagnostics A/S

See all devices from Medtronic Functional Diagnostics A/S →