Search Results
Found 2 results
510(k) Data Aggregation
K Number
K030857Device Name
MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES
Manufacturer
MAHE INTL., INC.
Date Cleared
2003-10-16
(212 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
MAHE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAHE Pediatric Naso-Pharyngoscope is intended for use only by qualified surgeons. Do not use the instrument for any purpose other than its intended application.
The MAHE Pediatric Naso-Pharyngoscope has been designed to be used with a light source, documentation equipment and video monitor for sinuscopy diagnosis and treatment within the nasal cavity and nasal pharynx.
The MAHE Pediatric Naso-Pharyngoscope is indicated for visual exam during diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.
The MAHE International Pediatric NASOPHARYNGOSCOPE is indicated for visual examination during a diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.
Device Description
The MAHE Pediatric Naso-Pharyngoscope has been designed to be used with a light source, documentation equipment and video monitor for sinuscopy diagnosis and treatment within the nasal cavity and nasal pharynx.
Ask a Question
K Number
K991426Device Name
MAHE INSTRUMENTS
Manufacturer
MAHE INTL., INC.
Date Cleared
1999-08-05
(104 days)
Product Code
FDC, FAS, FJL
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MAHE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE INTENDED USE FOR THE RESECTOSCOPE AND WORKING ELEMENTS IS IN UROLOGICAL PROCEDURES TO ENDOSCOPICALLY REMOVE, CUT, COAGULATE, AND OR TRANSECT TISSUE IN THE BLADDER, PROSTRATE, AND URETHRA. THE SURGEON PERFORMS THE EXAMINATION THROUGH THE URETHRA. THE DOCTOR CONTROLS THE BACK AND FORTH MOVEMENT OF THE ELECTRODE USING FINGER CONTROLS. THE WORKING ELEMENTS ALSO HOUSE A CYSTOSCOPE FOR VISALIZATION. THE HIGH FREQUENCY CABLE TRANSMITS ELECTRICAL CURRENT
Device Description
The Resectoscope is a reuasble non sterile urological instrument used with disposable sterile, single use electrodes for electro-cautery. The sheath and electrodes will be marketed in 24-27 French sizes.
Ask a Question
Page 1 of 1