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510(k) Data Aggregation
K Number
K201113Device Name
Resascope RS-01/B
Manufacturer
Date Cleared
2020-12-21
(238 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
Advanced Medical Systems Group SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
When used with a fibreoptic endoscope, Resascope is a video guided catheter intended to be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications
Device Description
The Resascope video guided catheter can be used in the lumbar and sacral epidural space to view the epidural anatomy, the pathology and to deliver approved drugs for epidural administration.
It can also be used by physicians to light and view the tissues in the epidural space of the lumbar and sacral spine, and in order to assist in the diagnosis of related pathologies, using a percutaneous approach through the sacral hiatus.
It is designed to be used by trained medical staff for less than 60 minutes usage time period.
lt is design with a soft tip and the addition of some blocks inside that allow the catheter to remain locked and therefore oriented, without return to zero.
The medical device is basically structured by two parts: the orientable catheter, intended to enter the peridural space, and the knob, to be used for the orientation of the catheter tip (tip flexion); on the knob there are connection tubes for inserting the endoscope and for connection to the infusion sets.
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K Number
K993740Device Name
MAMEX
Manufacturer
Date Cleared
1999-11-26
(22 days)
Product Code
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL SYSTEMS GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Provide the capabilities of performing upright biopsy.
Device Description
Mamex (Mammography System)
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