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510(k) Data Aggregation
K Number
K170112Device Name
IMD's Lumbar Puncture Needle
Manufacturer
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD)
Date Cleared
2018-02-02
(386 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDICAL DEVELOPMENT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMD's Lumbar Puncture Needle, a single patient use needle; it is intended to gain entry into or puncture the spinal cavity permitting injecting (including anesthesia) / withdrawl of fluids for purpose of diagnostic lumbar puncture, myelography discography procedures.
The device is intended for adult and pediatric patients.
It is to be used only under the direction of a licensed clinician.
Device Description
The IMD Inc. Lumbar Puncture Needle shares major similarities with the predicate device(s), in as much as the configuration, materials, area of use, and are identical to the IMD reference devices.
It consists of an introducer, stylet, and pencil-point needle, with plastic hubs, and stainless steel cannula. Offered in 18-27 gauges, and 3.5 in. (90 mm) and 5.0 in (124 mm) lengths.
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K Number
K070354Device Name
IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
Manufacturer
INTERNATIONAL MEDICAL DEVELOPMENT, INC
Date Cleared
2007-10-05
(241 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDICAL DEVELOPMENT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMD's specialty / anesthesia needles – Tuohy, Quincke and Pencil Point Needles – are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
Device Description
Anesthesia conduction needles consist of a luer hub, a stainless steel cannula with various tip types, and a stainless steel stylet. These needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in regional anesthesia trays (kits). 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 for longer pain relief.
The IMD anesthesia conduction needles - Tuohy, Quincke, and Pencil Point - are single use, sterile and latex-free medical devices for transient delivery of anesthetics during regional anesthesia. The cannula 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 regional 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.
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