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Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer Needle

by Innospine, Inc.

510(k) K043500

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK043500 Date15 Apr 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0948-2008 FDA Unclassified (pre-2012) initiated 25 Apr 2006

    Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.

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  • Withdrawn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
BSP
Device Class
Class II
Regulation
21 CFR Part 868.5150
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent