Search Results
Found 8 results
510(k) Data Aggregation
K Number
K061222Device Name
INJECTRA INJECTION NEEDLE
Manufacturer
MEDI-GLOBE CORP.
Date Cleared
2006-07-03
(62 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MEDI-GLOBE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medi-Globe® Injectra Needle is used in conjunction with various legally marked, FDA registered flexible endoscopes. The Injectra Needle is used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures.
Device Description
The Injectra Injection Needle is a device that is used to deliver solutions into tissues of the digestive tract through the accessory channel of a legally marketed endoscope.
Ask a Question
K Number
K051247Device Name
SONOTIP II ULTRASOUND NEEDLE SYSTEM
Manufacturer
MEDI-GLOBE CORP.
Date Cleared
2005-06-16
(31 days)
Product Code
FCG
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
MEDI-GLOBE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.
Device Description
The SonoTip 11 Ultrasound Needle System is complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single 101 I mo Noode Aspirature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This provides adjusted has been miss to precisely adjust the working length of the instrument to that of the specific ultrasound endoscope scope being used.
Ask a Question
K Number
K011261Device Name
STONE EXTRACTOR BALLOON CATHETER
Manufacturer
MEDI-GLOBE CORP.
Date Cleared
2003-11-17
(936 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
MEDI-GLOBE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K010714Device Name
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
Manufacturer
MEDI-GLOBE CORP.
Date Cleared
2003-01-21
(683 days)
Product Code
FGE, KNO
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
MEDI-GLOBE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medi-Globe Balloon Dilatation Catheters are intended to be used for Endoscopic Dilation of Biliary Tract, Esophageal or Shincter Stenosis.
Device Description
The balloon dilatation catheter is a nylon balloon mounted on a double lumen catheter. Proximately the device is fitted with either one or two luer fittings. The balloon dilatation catheters with balloon diameters larger than 12 millimeters have only one luer fitting that allows for balloon inflation. Balloon dilatation catheters with balloon diameters smaller than 12 millimeters have two luer fittings, one for passage of a guide wire and the other for balloon inflation.
Ask a Question
K Number
K010549Device Name
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
Manufacturer
MEDI-GLOBE CORP.
Date Cleared
2002-01-18
(326 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
MEDI-GLOBE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K990220Device Name
MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
Manufacturer
MEDI-GLOBE CORP.
Date Cleared
1999-03-31
(68 days)
Product Code
FCG
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
MEDI-GLOBE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GIP/ Medi-Globe Needle System for Ultrasonic FNA is specifically designed for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).
The Medi-Globe Needle System for Ultrasonic FNA is designed to be used with the Pentax FG32, 34, 36, 38 UA ultrasound endoscopes for ultrasonically guided fine needle aspiration (FNA of submucosal and extra-luminal lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).
Device Description
Not Found
Ask a Question
K Number
K953355Device Name
GIP/MEID-GLOBE HOT BIOPSY FORCEPS
Manufacturer
MEDI-GLOBE CORP.
Date Cleared
1996-04-04
(262 days)
Product Code
KGE
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
MEDI-GLOBE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
removal of small polyps in the GI track.
Device Description
The GIP/Medi-Globe Hot Biopsy Forceps are similar in design, composition (stainless steel and Teflon), and function and performance to the Wilson-Cook GI Hot Biopsy Forceps. The device is designed to be used in conjunction with numerous FDA Approved endoscopes. The entire device can be autoclaved or ETO gas sterilized. The Hot Biopsy Forceps are shipped assembled and sterile in a peel-open package. The working lengths of all of the GIP/Medi-Globe Hot Biopsy Forceps range from 1,200, 1,800, 2,300.
Ask a Question
K Number
K955558Device Name
GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES
Manufacturer
MEDI-GLOBE CORP.
Date Cleared
1996-02-29
(85 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MEDI-GLOBE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1