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Axonics 1501

by Axonics Modulation Technologies, Inc.

Axonics 1501 is a Class III device made by Axonics Modulation Technologies, Inc., approved under FDA PMA P190006 on 6 Sep 2019 and listed in FDA GUDID since 23 Sep 2019 (UDI-DI 10810005340028), active as of 23 Oct 2026. One FDA recall is linked to it.

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P190006

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 Number10810005340028 UDI-DI Date23 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP190006 Date6 Sep 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P190006 decided 6 Sep 2019 Active
  • FDA GUDID UDI-DI 10810005340028 listed 23 Sep 2019 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0198-2027 FDA Not yet classified initiated 15 Jul 2024

    Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.

Timeline

3 dated events

  1. Approved FDA PMA P190006
  2. Listed FDA GUDID 10810005340028
  3. Recall initiated FDA recalls Z-0198-2027

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Axonics
Generic name
Implantable incontinence-control electrical stimulation system programmer, line-powered
Model / Ref / Catalog
1501
Primary DI / UDI-DI
10810005340028
PMA number
FDA product code
EZW
GMDN term
Implantable incontinence-control electrical stimulation system programmer, line-powered
Device class
Class III
Regulation number
876.5270
GUDID distribution status
In Commercial Distribution

Related devices

Category: Implantable incontinence-control electrical stimulation system programmer, line-powered

Cleared under the same submission (P190006)

Similar devices

Other devices filed under FDA product code EZW (Stimulator, Electrical, Implantable, For Incontinence).

Other devices from Axonics Modulation Technologies, Inc.

  • Axonics 4101

    Class III

  • Axonics 1401

    Class III

  • Axonics 5101

    Class III

  • Axonics FFG-01 Open recall

    Class III

See all devices from Axonics Modulation Technologies, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)