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3009

by Advanced Neuromodulation Systems

3009 is a Class II device made by Advanced Neuromodulation Systems, cleared under FDA 510(k) K070847 on 11 Apr 2007 (1 earlier submission) and listed in FDA GUDID since 25 Apr 2015 (UDI-DI 05414734401500), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05414734401500 UDI-DI Date25 Apr 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK070847 Date11 Apr 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070847 decided 11 Apr 2007 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05414734401500 listed 25 Apr 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K033757
  2. Cleared FDA 510(k) K070847
  3. Listed FDA GUDID 05414734401500

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Pin-indexed adaptor, reusable
Model / Ref / Catalog
3009
Primary DI / UDI-DI
05414734401500
510(k) Number
FDA product code
GZB
GMDN term
Pin-indexed adaptor, reusable
Device class
Class II
Regulation number
882.5880
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Pin-indexed adaptor, reusable.

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  • Proclaim™ 3884 Open recall

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See all devices from Advanced Neuromodulation Systems →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)