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Axonics FFG-01

by Axonics Modulation Technologies, Inc.

Axonics FFG-01 is a Class III device made by Axonics Modulation Technologies, Inc., approved under FDA PMA P180046 on 13 Nov 2019 (1 earlier submission) and listed in FDA GUDID since 5 Feb 2025 (UDI-DI 10810005340523), 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 P180046

+1 more

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10810005340523 UDI-DI Date5 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP180046 Date13 Nov 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P180046 decided 13 Nov 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10810005340523 listed 5 Feb 2025 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

4 dated events

  1. Approved FDA PMA P190006
  2. Approved FDA PMA P180046
  3. Recall initiated FDA recalls Z-0198-2027
  4. Listed FDA GUDID 10810005340523

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  • Withdrawn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
Medical ruler, single-use
Model / Ref / Catalog
FFG-01
Primary DI / UDI-DI
10810005340523
PMA number
FDA product code
EZW, QON
GMDN term
Medical ruler, single-use
Device class
Class III
Regulation number
876.5270
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical ruler, single-use

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 9108-R

    Class III

See all devices from Axonics Modulation Technologies, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)