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Radiofrequency Cannula 120008430

by Avanos Medical, Inc. United States GUDID

Product code GXI

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00193493000814 UDI-DIDate31 Aug 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

2 recalls · FDA

    • Terminated Z-0850-2014 FDA Class II initiated 29 Oct 2013

    Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.

    • Terminated Z-0879-2013 FDA Class II initiated 4 Oct 2012

    A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. Thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. The cannulas were not used on any patients, as the unsealed packages

Specification

GUDID · synced 23 Oct 2026

Trade Name
Radiofrequency Cannula
Generic Name
Percutaneous radio-frequency ablation probe cannula, single-use
Model / Ref / Catalog
120008430, PMC16-100-10CS
Primary DI / UDI-DI
00193493000814
510(k) Number
FDA Product Code
GXI
GMDN Term
Percutaneous radio-frequency ablation probe cannula, single-use
Device Class
Class II
Regulation Number
882.4725
Commercial Distribution
In Commercial Distribution
Size
Length — 100 Millimeter
Catheter Gauge — 16 French

Related devices

Cleared under the same submission (K972846)

Show all (12)

Other devices from Avanos Medical, Inc.

See all devices from Avanos Medical, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (10)
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 3f051cd6-a158-432c-beeb-f0f45249ff1b 36 fields · synced 23 Oct 2026