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510(k) Data Aggregation
K Number
K191293Device Name
LCCS VC-S RF Cannula
Manufacturer
LCCS Products Limited
Date Cleared
2020-01-24
(255 days)
Product Code
GXI
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
LCCS Products Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LCCS VC-S RF Cannula is intended for use in RF heat lesion procedures for the relief of pain.
Device Description
The LCCS VC-S RF Cannula is used in conjunction with the RF electrode for the use in RF heat lesion procedures. The LCCS VC-S RF Cannulas are offered in a variety of lengths, gauges to accommodate various anatomical locations and differences in patients' anatomy. The LCCS VC-S RF Cannula is a stainless steel cannula with an insulated shaft having one exposed tip and one side port located at the end of the cannula to diffuse the anesthesia closer to the lesion site and deliver the RF energy to the tissue. When RF Electrode was inserted into LCCS VC-S RF Cannula and came out from the side port, both active tip and RF Electrode section stuck out of side port can deliver Radio Frequency energy. This RF cannula is provided as a sterile, single use, disposable device. This RF Cannula is offered in a variety of length and Needle outside Dimension to accommodate various anatomical locations and differences in patient anatomy. The LCCS VC-S RF Cannula is consisted of: Protection Sleeve, Needle Tube, Insulating layer, Needle hub, Stylet, Stylet Hub.
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K Number
K152642Device Name
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
Manufacturer
LCCS PRODUCTS LIMITED
Date Cleared
2016-08-26
(346 days)
Product Code
GXI
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
LCCS PRODUCTS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LCCS Radiofrequency (RF) Electrode is indicated for use in temperature-controlled RF heat lesson procedures of peripheral nerve tissue for the relief of pain.
Device Description
LCCS Radiofrequency (RF) Electrode is used in conjunction with RF Generator to create RF lesions of nerve tissue or for use in percutaneous nerve blocks. The RF Electrode connects with RF Generator and thermocouple side which fits in with RF Cannula. The RF generator applies temperature-controlled RF energy into targeted nerve tissue via an RF Electrode to create a heat lesioning of peripheral nerve tissue.
LCCS RF Electrode includes LCCS Disposable RF Electrode and LCCS Reusable RF Electrode. LCCS Disposable RF Electrode Part No. includes RE2750-D-LC, RE27100-D-LC, RE27150-D-LC, and RE27200-D-LC.
LCCS Reusable RF Electrode Part No. includes RE2750-R-LC, RE27100-R-LC, RE27150-R-LC, RE27200-R-LC, RE2550-R-LC, RE25100-R-LC, RE25150-R-LC, and RE25200-R-LC.
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K Number
K131006Device Name
ANESTHESIA CONDUCTION NEEDLES
Manufacturer
LCCS PRODUCTS LIMITED
Date Cleared
2013-12-06
(239 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
LCCS PRODUCTS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AN-E epidural needle is intended for the transient delivery of anesthetics to provide neuraxial anesthesia or to facilitate placement of an epidural catheter.
AN-SI spinal needle and AN-SII spinal needle are intended for the transient delivery of anesthetics to provide neuraxial anesthesia.
Device Description
The proposed device, Anesthesia conduction needles, including Epidural Needle for Single Use (AN-E), Spinal Needle for Single Use (AN-SI, AN-SII) was developed by LCCS Products Limited to meet urgent demands on prevention of cross- infection. Anesthesia conduction needles, is a kind of sterile and sharp hollow-device used for transferring anaesthetic to epidural cavities. The device can be used for introducing dedicated ducts into epidural cavities for convenience of injecting anaesthetic continuously. Anesthesia conduction needles fit into an introducer needle. This is a simple hypodermic needle to make the initial puncture through the skin to aid in the placement of the anesthesia conduction needle. The later can facilitate the placement of an epidural catheter for continuous infusion of local anesthetics into the epidural space. The needle tubing is stabilized during puncture with use of an inner stylet. This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for neuraxial anesthesia. Then the anesthetics can be applied transiently (i.e., within minutes) by the professional anesthetist. Alternatively or additionally, an epidural catheter may be placed through the anesthesia conduction needle. The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.The stylet hub is made of HDPE, the needle hub is made of resin, the raw material of the needle tubing and stylet is stainless steel, the jacket is PP, all the raw materials are biocompatible.
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K Number
K132136Device Name
SINGLE USE GROUNDING PAD
Manufacturer
LCCS PRODUCTS LIMITED
Date Cleared
2013-09-06
(57 days)
Product Code
GEI, JOS
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LCCS PRODUCTS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single Use Grounding Pad is applied to the patient during electrosurgical procedures to provide a path for the RF current to leave the patient and return to the generator.
Device Description
The single use grounding pad is a non-sterile dispersive electrode with a pre-attached cord. The purpose of the return electrode is to complete the electrosurgical circuit between the generator, the active electrode and the patient. The grounding pad is to be used on any patient where full skin contact and a suitable placement site can be obtained. Use of this device for unintended application could lead to an unsafe condition.
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K Number
K112231Device Name
LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
Manufacturer
LCCS PRODUCTS LIMITED
Date Cleared
2011-08-19
(15 days)
Product Code
GXI
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
LCCS PRODUCTS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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