Who else makes this device?

Name: Intracept RF Probe
Brand: Intracept RF Probe

Neurology › SurgicalProbe, Radiofrequency Lesion

Intracept RF Probe

2 catalogue numbers from RLV 0015, listed by Relievant Medsystems, United States, under Probe, Radiofrequency Lesion. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

6510(k) clearances naming this product code

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 Intracept RF Probe
Listed by	Relievant Medsystems, United States
FDA product code	GXI
Device type	Probe, Radiofrequency Lesion
Device class	Class 2
Regulation	21 CFR 882.4725
Record published	2023-03-07
Record revised	2025-08-07 (version 5)

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, expiry date
Storage	Storage environment temperature up to 120 °F
Distribution end date	2023-03-07

Catalogue Numbers

Catalogue numbers for Intracept RF Probe
Catalogue number	Size	Status
RLV 0015		In distribution
RLV 0015		Withdrawn

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
K222281	2022-10-26
K213836	2022-03-11
K190504	2019-05-03
K180369	2018-09-14
K170827	2017-08-09
K153272	2016-07-09

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.