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Octrode™ 3086

by St. Jude Medical, Inc.

Part of a family of 48 devices: see the family page

Ref 3086

Octrode™ 3086 is a device classified as Class III in the EU and Class II in the US made by St. Jude Medical, Inc., registered in EUDAMED on 29 Jun 2026 (Basic UDI-DI 5415067SCS0001L4) with CE/MDR certificate MDR 750959 valid until 11 Oct 2027, cleared under FDA 510(k) K960728 on 22 May 1996 and listed in FDA GUDID since 25 Apr 2015 (UDI-DI 05414734401555), active as of 23 Oct 2026.

Expiring Expiring in European Union. Active in United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

11 Oct 2027

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K960728

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067SCS0001L4 Basic UDI-DI 05414734401555UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414734401555 UDI-DI Date25 Apr 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK960728 Date22 May 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5415067SCS0001L4 registered 29 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K960728 decided 22 May 1996 Active
  • FDA GUDID UDI-DI 05414734401555 listed 25 Apr 2015 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 750959 Expiring Supplemented Expires in 333 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    24 Jun 2026
    Expires
    11 Oct 2027
    Reason
    Add device or group

Timeline

5 dated events

  1. Cleared FDA 510(k) K960728
  2. Listed FDA GUDID 05414734401555
  3. Certificate issued EUDAMED MDR 750959
  4. Registered EUDAMED 5415067SCS0001L4
  5. Certificate expires EUDAMED MDR 750959

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Octrode™
Generic name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Device name
Spinal Cord Stimulation
Model / Ref / Catalog
3086
Primary DI / UDI-DI
05414734401555
Basic UDI-DI
5415067SCS0001L4
510(k) Number
FDA product code
GZB
EMDN code
J020203 Spinal neurostimulation leads
GMDN term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.5880
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 60 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

Cleared under the same submission (K960728)

and 2 more cleared under K960728

Similar devices in this category

Other devices filed under SPINAL IMPLANTABLE NEUROSTIMULATORS.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (19, all answered No)