FDA.reportPublic FDA data

LCCS

Primary DI
04895233604646
Brand
LCCS
Company
LCCS Products Limited
Model
C-1015-Y-16-LC
Device description
Single-use RF Cannula
Published
2023-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXIProbe, Radiofrequency Lesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112231000LCCS INSULATED SPINAL NEEDLE (RF CANNULA)Lccs Products Limited2011-08-19GXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14895233604643PackageGS125In Commercial Distribution
64895233604648PackageGS140In Commercial Distribution
04895233604646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489523360464314895233604643
6489523360464864895233604648
04895233604646048952336046464895233604646

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe cannula, single-useA rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (RF) ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1 (844) 743-6449info@lccsmedical.com

Regulatory Flags#

DUNS number
663190222
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04895233611019LCCS3508-LCCS2026-01-13
04895233611026LCCS3406-LCCS2026-01-13
64895233611011LCCS3508-LCCS2026-01-13
64895233611028LCCS3406-LCCS2026-01-13
04895233602369LCCSS-505-20-LC2025-11-17
14895233602366LCCSS-505-20-LC2025-11-17
04895233606565LCCSSQ22155-LC2025-09-15
14895233606562LCCSSQ22155-LC2025-09-15
04895233608149LCCSET20125-LC2025-08-29
14895233608146LCCSET20125-LC2025-08-29
04895233609245LCCSCSE25125-1790-LC2024-06-03
14895233609242LCCSCSE25125-1790-LC2024-06-03
04895233606275LCCSSQE2590-LC2024-06-02
04895233609252LCCSCSE25125-1890-LC2024-06-02
04895233609511LCCSSQE2590-LC2024-06-02
04895233609535LCCSSQE25155-LC2024-06-02
04895233609610LCCSSQE2290-LC2024-06-02
04895233609627LCCSSQE22125-LC2024-06-02
04895233609634LCCSSQE22155-LC2024-06-02
04895233609719LCCSSQE2075-LC2024-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450452346ViaVerte™Merit Medical Systems, Inc.GXI2026-05-19
07613327601121OptaBlateSTRYKER CORPORATIONGXI2025-05-27
07613327601169OptaBlateSTRYKER CORPORATIONGXI2025-05-27
10195327666354Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-11-03
M661SST221505Radiofrequency (RF) NeedleSpectra Medical Devices, LLCGXI2024-06-18
10195327493172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493189Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
10195327493202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2024-01-07
20763000835631AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835648AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
20763000835655AccurianMEDTRONIC SOFAMOR DANEK, INC.GXI2023-09-25
10195327047030Medline Industries, Inc.MEDLINE INDUSTRIES, INC.GXI2022-08-04
00193493000265COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000272COOLIEF*Avanos Medical, Inc.GXI2022-03-17
00193493000296AVANOS*Avanos Medical, Inc.GXI2022-03-12
00193493000302AVANOS*Avanos Medical, Inc.GXI2022-03-12
00193493000326COOLIEF*Avanos Medical, Inc.GXI2022-03-12
00193493985920AVANOS*Avanos Medical, Inc.GXI2022-03-12
00191506013097SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013103SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013110SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00191506013127SideKick™ 2BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGXI2021-04-28
00193493000159AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000166AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000173AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000197AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493000203AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478804AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478811AVANOSAvanos Medical, Inc.GXI2021-03-11
00193493478828AVANOSAvanos Medical, Inc.GXI2021-03-11