Search Results
Found 2 results
510(k) Data Aggregation
K Number
K970937Device Name
MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)
Manufacturer
Date Cleared
1997-09-26
(197 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MIST, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MIST Micro Interchangeable Scope System ™ is intended to be used by trained physicians for the illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures.
The MIST Micro Interchangeable Scope Systems are rigid, two piece fiber-optic endoscopes intended for the illumination and direct visualization of body cavities, hollow organs and canals during general diagnostic procedures.
Device Description
The MIST Micro Interchangeable Scope System ™ is a two piece, rigid, fiberoptic laparoscope. The universal eyepiece (MicroView Handle)) may be used with several variable sizes of shafts. No working channel is provided.
The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.
Ask a Question
Ask a specific question about this device
K Number
K971150Device Name
MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE
Manufacturer
Date Cleared
1997-09-23
(179 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MIST, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MIST Panoramic Laparoscope is intended to be used by trained physicians for the illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures.
The MIST Panoramic Laparoscope is a rigid laparoscope intended for the illumination and direct visualization of body cavities, hollow organs and canals for the purpose of diagnosis of diseases and/or minimally invasive general surgeries.
Device Description
The MIST Panoramic Laparoscope is a rigid, fiber-optic laparoscope. No working channel is provided.
The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.
Ask a Question
Ask a specific question about this device
Page 1 of 1