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Octrode™ 3086

by St. Jude Medical, Inc. 2 variants

Octrode™ 3086 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K960728 on 22 May 1996 and listed in FDA GUDID since 15 Oct 2015 (UDI-DI 05414734406024), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K960728

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05414734406024 UDI-DI Date15 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK960728 Date22 May 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K960728 decided 22 May 1996 Active
  • FDA GUDID UDI-DI 05414734406024 listed 15 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K960728
  2. Listed FDA GUDID 05414734406024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Octrode™
Generic name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Model / Ref / Catalog
3086
Primary DI / UDI-DI
05414734406024
510(k) Number
FDA product code
GZB
GMDN term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Device class
Class II
Regulation number
882.5880
GUDID distribution status
In Commercial Distribution
Size
Length — 60 Centimeter

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

Other devices from St. Jude Medical, Inc.

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

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (8, all answered No)