Cannulaflextrode

Cannula 15cm, 17G

Registry build 21.09.26
1manufacturer
1catalogue number
4510(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 cannulaFlextrode
Listed by Cosman Medical, Inc., United States
FDA product code GXI
Device type Probe, Radiofrequency Lesion
Device class Class 2
Regulation 21 CFR 882.4725
Record published 2016-10-25
Record revised 2023-05-03 (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
Distribution end date 2020-08-11

Catalogue Numbers

Catalogue numbers for cannulaFlextrode
Catalogue number Size Status
FLEX-C15 Withdrawn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
K082012 2008-10-14
K060799 2006-05-02
K053415 2006-04-25
K050084 2005-03-17

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer