Halyard
COOLIEF* Cooled Radiofrequency Probe KIt-Typical Anatomy Placement: Lumbar Spine, Knee, Hip-17-100-4-CRP-17-100
1manufacturer
156catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| 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) | K071745 |
| Record published | 2017-09-29 |
| Record revised | 2023-05-03 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 10 |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12482 | In distribution | |
| 98631 | In distribution | |
| 98671 | In distribution | |
| 98698 | In distribution | |
| 98669 | In distribution | |
| 98449 | In distribution | |
| 44191 | In distribution | |
| 12521 | In distribution | |
| 98678 | In distribution | |
| 99715 | In distribution | |
| 98637 | In distribution | |
| 98640 | In distribution | |
| 30392 | In distribution | |
| 98635 | In distribution | |
| 44210 | In distribution | |
| 46939 | In distribution | |
| 98686 | In distribution | |
| 98670 | In distribution | |
| 98634 | In distribution | |
| 12481 | In distribution | |
| 30390 | In distribution | |
| 12548 | In distribution | |
| 98638 | In distribution | |
| 40588 | In distribution | |
| 12511 | In distribution | |
| 12866 | In distribution | |
| 98664 | In distribution | |
| 98628 | In distribution | |
| 12477 | In distribution | |
| 98665 | In distribution | |
| 12515 | In distribution | |
| 38549 | In distribution | |
| 98644 | In distribution | |
| 47876 | In distribution | |
| 99589 | In distribution | |
| 12483 | In distribution | |
| 98673 | In distribution | |
| 44195 | In distribution | |
| 12480 | In distribution | |
| 12516 | In distribution | |
| 30748 | In distribution | |
| 98663 | In distribution | |
| 12545 | In distribution | |
| 30751 | In distribution | |
| 12523 | In distribution | |
| 99711 | In distribution | |
| 12551 | In distribution | |
| 46942 | In distribution | |
| 98630 | In distribution | |
| 12487 | In distribution | |
| 44075 | In distribution | |
| 98679 | In distribution | |
| 12489 | In distribution | |
| 46934 | In distribution | |
| 98685 | In distribution | |
| 30802 | In distribution | |
| 98595 | In distribution | |
| 12520 | In distribution | |
| 12518 | In distribution | |
| 30395 | In distribution | |
| 98667 | In distribution | |
| 09693 | In distribution | |
| 44194 | In distribution | |
| 44076 | In distribution | |
| 38550 | In distribution | |
| 44202 | In distribution | |
| 98689 | In distribution | |
| 98627 | In distribution | |
| 44077 | In distribution | |
| 30747 | In distribution | |
| 44206 | In distribution | |
| 44254 | In distribution | |
| 12504 | In distribution | |
| 30744 | In distribution | |
| 12546 | In distribution | |
| 30391 | In distribution | |
| 44193 | In distribution | |
| 99714 | In distribution | |
| 44209 | In distribution | |
| 30394 | In distribution | |
| 99634 | In distribution | |
| 39318 | In distribution | |
| 11183 | In distribution | |
| 98694 | In distribution | |
| 98691 | In distribution | |
| 98633 | In distribution | |
| 98666 | In distribution | |
| 12484 | In distribution | |
| 44203 | In distribution | |
| 12510 | In distribution | |
| 98626 | In distribution | |
| 99708 | In distribution | |
| 98629 | In distribution | |
| 98697 | In distribution | |
| 98643 | In distribution | |
| 98662 | In distribution | |
| 12524 | In distribution | |
| 30396 | In distribution | |
| 98645 | In distribution | |
| 47877 | In distribution | |
| 44205 | In distribution | |
| 46932 | In distribution | |
| 98622 | In distribution | |
| 12485 | In distribution | |
| 12519 | In distribution | |
| 46938 | In distribution | |
| 30743 | In distribution | |
| 12502 | In distribution | |
| 12522 | In distribution | |
| 98642 | In distribution | |
| 46935 | In distribution | |
| 39321 | In distribution | |
| 12547 | In distribution | |
| 30745 | In distribution | |
| 12488 | In distribution | |
| 12513 | In distribution | |
| 12495 | In distribution | |
| 12506 | In distribution | |
| 98625 | In distribution | |
| 44201 | In distribution | |
| 30604 | In distribution | |
| 12549 | In distribution | |
| 99581 | In distribution | |
| 12474 | In distribution | |
| 40590 | In distribution | |
| 30445 | In distribution | |
| 11184 | In distribution | |
| 44200 | In distribution | |
| 98672 | In distribution | |
| 30397 | In distribution | |
| 11182 | In distribution | |
| 30746 | In distribution | |
| 46936 | In distribution | |
| 46929 | In distribution | |
| 98683 | In distribution | |
| 98674 | In distribution | |
| 98636 | In distribution | |
| 12526 | In distribution | |
| 98661 | In distribution | |
| 98693 | In distribution | |
| 30398 | In distribution | |
| 46933 | In distribution | |
| 98624 | In distribution | |
| 30393 | In distribution | |
| 40589 | In distribution | |
| 12493 | In distribution | |
| 40608 | In distribution | |
| 98632 | Withdrawn | |
| 30803 | Withdrawn | |
| 30749 | Withdrawn | |
| 40529 | Withdrawn | |
| 98413 | Withdrawn | |
| 98448 | Withdrawn | |
| 30750 | Withdrawn | |
| 99668 | Withdrawn | |
| 99590 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OWL | Diros Technology, Inc. | 345 |
| Probe, Radiofrequency Lesion | Boston Scientific Neuromodulation Corporation | 175 |
| 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 |
| Epimed | Minta Medical Limited | 35 |
Showing 12 of 85. All products under Probe, Radiofrequency Lesion
510(K) Clearances
| 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.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Avanos Medical, Inc. | 510(k) number | 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 |
| Baylis Medical Technologies Inc. | 510(k) number | 2010-05-12 | Not classified | Error in labeling | Name of the device reflected on the product packing sleeve is incorrect. | 58 | 2010-10-04 |
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.