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510(k) Data Aggregation
K Number
K122411Device Name
J-SCOPE SYSTEM
Manufacturer
Date Cleared
2013-02-11
(187 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
MYELOTEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The J-Scope System is an endoscopic device intended to be used by physicians for introduction of fluids to assist in visualization of intra-articular structures for arthroscopic diagnosis, as well as for surgical procedures using a second J-Scope or other arthroscopic device. It is indicated for use in the shoulder, hip, wrist, ankle, knee, and elbow joints.
Device Description
The J-Scope Tissue Visualization & Assessment Mini-Cannula Kit is a single-use, disposable small diameter, 14-gauge needle mini-cannula device which, when coupled with the J-Scope semi-rigid or flexible Arthroscope, provides convenient and precise arthroscopic visualization of both major and minor joints. The micro-invasive design of the system allows the procedure to be performed comfortably with the patient under local anesthesia.
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K Number
K980734Device Name
MYELOTEC VIDEO GUIDED CATHETER
Manufacturer
Date Cleared
1998-08-11
(167 days)
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
MYELOTEC, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
when used with a fiberoptic endoscope, this device can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.
Device Description
The MYELOTEC VIDEO GUIDED CATHETER (VGC) consists of a flexible double lumen catheter, steering handle and associated ports for access to the lumens. The catheter has a built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. Each lumen is one (1) mm in diameter. The design allows the use of a flexible fiber optic endoscope for visual examination of the area and surrounding tissues at the distal end of the catheter. This visual examination then allows the physician to diagnose the potential causes of neural distress and pain.
The port on the second lumen allows the injection of saline to expand the space and expose the source of distress for viewing and treatment. The port also facilitates the connection of syringes to deliver physician selected therapeutic agents as appropriate to their diagnosis.
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K Number
K960194Device Name
MYELOTEC MYELOSCOPE
Manufacturer
Date Cleared
1996-09-04
(232 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
MYELOTEC, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Myeloscope is intended to be used by physicians for the illumination and The Mydlescope is intenthe epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.
Device Description
The Myelotec Myeloscope is a flexible fiberoptic system that includes a video guided catheter that allows steering of the fiberoptic scope. The fiberoptic scope is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The video guided catheter is a sterile, disposable device.
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