Search Results
Found 4 results
510(k) Data Aggregation
K Number
K001563Device Name
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
Manufacturer
SCION CARDIOVASCULAR, INC.
Date Cleared
2000-11-22
(187 days)
Product Code
FGO
Regulation Number
876.4680Why did this record match?
Product Code :
FGO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K970121Device Name
STONE DISLODGER, BASKET
Manufacturer
BOSTON SCIENTIFIC CORP.
Date Cleared
1997-04-02
(78 days)
Product Code
FGO
Regulation Number
876.4680Why did this record match?
Product Code :
FGO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The proposed Stone Dislodger is intended to be used during urological and/or gastroenterological procedures including use during intracorporeal lithotripsy, to endoscopically grasp, manipulate and remove calculi and other foreign objects.
Device Description
2Fr, 8.3 mm Stone Dislodger Basket, Helical Design
Ask a Question
K Number
K963750Device Name
RETRIEVAL SNARE
Manufacturer
BOSTON SCIENTIFIC CORP.
Date Cleared
1996-11-22
(65 days)
Product Code
FGO
Regulation Number
876.4680Why did this record match?
Product Code :
FGO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Retrieval Snare is indicated for use in grasping and retrieval of foreign body within the alimentary tract. These foreign bodies may include guidewires, pullwires, or plastic stents.
Device Description
Not Found
Ask a Question
K Number
K962676Device Name
DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
Manufacturer
UNITED STATES ENDOSCOPY GROUP, INC.
Date Cleared
1996-10-04
(87 days)
Product Code
FGO
Regulation Number
876.4680Why did this record match?
Product Code :
FGO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoscopic Retrieval is a procedure whereby a foreign body, polyp or tissue, stone or calculi is removed from the gastrointestinal tract or biliary tract. A retrieval device is an instrument which enables the physician to grasp and retrieve the object via endoscopic methods.
Device Description
The retrieval basket is introduced through an endoscope and the basket is placed around the object. Retrieval baskets have been clinically used for more than 20 years.
Ask a Question
Page 1 of 1