Who else makes this device?

Name: Radiofrequency Cannulae
Brand: Radiofrequency Cannulae

Radiofrequency Cannulae · Probe, Radiofrequency Lesion → Neurology

1manufacturer

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GXI
Manufacturer	City	Province	Registered as	Device types
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24

Record

Regulatory record for Radiofrequency Cannulae
Listed by	Avanos Medical, Inc., United States
FDA product code	GXI
Device type	Probe, Radiofrequency Lesion
Device class	Class 2
Regulation	21 CFR 882.4725
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K972846
Record published	2020-07-25
Record revised	2023-06-22 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
Packaging	Dsp of 10, case of 20

Catalogue Numbers

Catalogue numbers for Radiofrequency Cannulae
Catalogue number	Size	Status
PMF22-100-5		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
OWL	Diros Technology, Inc.	345
Probe, Radiofrequency Lesion	Boston Scientific Neuromodulation Corporation	175
Halyard	Avanos Medical, Inc.	156
Lccs	Lccs Products Limited	101
Epimed	Epimed International, Inc.	100
Avanos	Avanos Medical, Inc.	89
NeuroTherm™	Neurotherm, Inc.	87
Probe, Radiofrequency Lesion	St. Jude Medical	66
cannulaRFK	Cosman Medical, Inc.	56
Rftl	Pajunk Gmbh Medizintechnologie	54
Radiofrequency (RF) Needle	Spectra Medical Devices, LLC	49
cannulaCC	Cosman Medical, Inc.	47

Showing 12 of 85. All products under Probe, Radiofrequency Lesion

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K203066	2020-12-22

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Radiofrequency Cannulae
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Kimberly-Clark Corporation	510(k) number	2013-10-29	Class II	Employee error	Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.	55 cases (10 units per case = 550 units)	2014-09-03
Baylis Medical Technologies Inc.	510(k) number	2012-10-04	Class II	Packaging	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 th	1780	2013-05-23

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-06-16	Class II	Process control	Mismatch between the length of the RF electrode (probe) and the cannula (introducer),	51 kits	2016-09-08

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Radiofrequency Cannulae