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Found 10 results
510(k) Data Aggregation
K Number
K190492Device Name
Peralta Stone Removal Catheter
Manufacturer
Calcula Technologies, Inc
Date Cleared
2019-07-18
(140 days)
Product Code
FFL, EZN
Regulation Number
876.4680Why did this record match?
Product Code :
FFL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Peralta Stone Removal Catheter is intended to be used endoscopically to grasp, manipulate, and remove calculi from the urinary tract, and/or for ureteral dilation.
Device Description
The Peralta Stone Removal Catheter (Peralta) is a 3 French (1 mm) catheter designed for removal of ureteral stones and fragments that are 5 mm or less in diameter in the urinary tract and ureteral dilation. The catheter uses a wire basket to encapsulate the stone, and a noncompliant balloon which can be inverted around the basket to cover the sharp edges of the stone during removal. The balloon can also be used for dilation of the urinary tract.
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K Number
K172299Device Name
Accordion Piccolo Stone Management Device
Manufacturer
THS International, Inc. d/b/a Accordion Medical
Date Cleared
2017-09-19
(50 days)
Product Code
FFL
Regulation Number
876.4680Why did this record match?
Product Code :
FFL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accordion Piccolo Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.
Device Description
The Accordion Piccolo's film membrane is attached to a two-part (inner and outer shaft) guidewire and deploys within the lumen of the ureter. The device can be advanced via the working channel of a cystoscope, and advanced under direct vision or fluoroscopy until the tip is proximal to the kidney stone or foreign object. To contain the stone during lithotripsy or entrap a foreign object, the movable core of the guidewire component is advanced by pulling on the handle, which causes the film membrane to deploy within the lumen of the ureter and prevent proximal movement of the stone or object during the surgical procedures. The physician may maintain the film membrane in the deployed position and "sweep" the stone fragments down the ureter and into the bladder or use the deployed film as a "backboard" to prevent migration of the stone fragments into the kidney as he/she removes the fragments with a basket or other device.
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K Number
K102887Device Name
ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
Manufacturer
PERCUTANEOUS SYSTEMS, INC.
Date Cleared
2011-05-16
(228 days)
Product Code
FFL
Regulation Number
876.4680Why did this record match?
Product Code :
FFL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PercSys Accordion® Stone Management Device is intended to be used in endoscopic procedures to bypass, entrap and remove calculi and other foreign objects from the urinary tract, to prevent retrograde migration of calculi during lithotripsy, and to guide instrumentation within the ureter.
Device Description
The Accordion device consists of a film membrane preloaded onto a two-part wire guide with a removable handle. The device is advanced within the urinary system similar to a wire guide, then, once the film membrane is in the desired position, the film folds into a helical coil (a film-based occlusion) which occupies the lumen of the anatomy in which it resides. In this manner, the occlusion limits migration of stones and stone fragments during lithotripsy. The shaft of the device is 0.97mm (0.038 inch) in outer diameter, has a 150 cm working length, and the film occlusion can be formed into either a 7 mm or 10 mm diameter helical coil. The device is visible under fluoroscopic imaging due to marker bands on either side of the film component and radiopaque disc embedded in the film. The Accordion device is provided sterile and is a single-use only device.
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K Number
K082803Device Name
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
Manufacturer
PERCUTANEOUS SYSTEMS, INC.
Date Cleared
2008-11-13
(50 days)
Product Code
FFL
Regulation Number
876.4680Why did this record match?
Product Code :
FFL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coaxial Accordion Stone Management Device Urological is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and facilitate drainage and retrograde pyelogram.
Device Description
The Coaxial Accordion Stone Management Device consists of a film membrane attached onto a cannula with a removable handle.
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K Number
K052048Device Name
ACCORDION
Manufacturer
PERCUTANEOUS SYSTEMS, INCORPORATED
Date Cleared
2005-09-13
(46 days)
Product Code
FFL
Regulation Number
876.4680Why did this record match?
Product Code :
FFL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ACCORDION Urolgoical Occluding Guidewire is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.
Device Description
The ACCORDION Urological Occluding Guidewire consists of a film The ACCORDION Orological Other a two-part guidewire with a removable handle.
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K Number
K012581Device Name
REPROCESSED STONE RETRIEVAL BASKETS
Manufacturer
STERILMED, INC.
Date Cleared
2002-02-14
(189 days)
Product Code
FFL
Regulation Number
876.4680Why did this record match?
Product Code :
FFL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed Stone Retrieval Baskets are used to entrap and remove renal stones and calculi via a rigid or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures.
Device Description
SterilMed's reprocessed stone retrieval baskets consist of a handle, shaft/sleeve, and a wire basket which serves as the stone capturing mechanism. They come in diameters ranging from 1.9 French to 8.0 French, and lengths ranging from 70 cm to 220 cm. The baskets are available in 3 to 8 wire configurations and flat or helical wire designs.
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K Number
K972091Device Name
AMS FOREIGN BODY EXTRATOR
Manufacturer
AMERICAN MEDICAL SYSTEMS, INC.
Date Cleared
1997-08-29
(86 days)
Product Code
FFL
Regulation Number
876.4680Why did this record match?
Product Code :
FFL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMS Foreign Body Extractor is intended for use in the removal of a foreign body from the bladder under direct vision.
Device Description
The AMS Foreign Body Extractor is made of stainless steel and consists of an obturator, sheath, grasper, seals, handle, security clip, telescope stabilizers and ACMI adaptor ring. The AMS Foreign Body Extractor Accessory Kit contains replacement security clip, telescope stabilizers, ACMI adaptor ring, and seals. To facilitate insertion into the urethra and bladder, the obturator is placed inside the sheath. Once inside the bladder, the obturator is removed and the grasper is placed within the lumen of the sheath. The handle is then attached and the telescope inserted into the sheath. The grasping jaws are operated by moving the handle to open and close the grasping jaws to capture and remove the foreign body.
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K Number
K970489Device Name
COMEG ENDOSCOPY GRASPING FORCEPS
Manufacturer
COMEG ENDOSCOPY
Date Cleared
1997-03-19
(37 days)
Product Code
FFL
Regulation Number
876.4680Why did this record match?
Product Code :
FFL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the foreign body grasping forceps is in urological procedures to endoscopically remove, manipulate or grasp calculi (i.e. stones) and other foreign objects.
Device Description
The COMEG Endoscopy devices that we intend to market are foreign body Grasping Forceps. These forceps are composed of stainless steel. They have diameters of 7 and 9 French and lengths of 40 cm. Each model has an alligator jaw with a standard double action mechanism.
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K Number
K962387Device Name
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
1996-07-31
(41 days)
Product Code
FFL
Regulation Number
876.4680Why did this record match?
Product Code :
FFL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961248Device Name
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS
Manufacturer
C.R. BARD, INC.
Date Cleared
1996-05-28
(57 days)
Product Code
FFL
Regulation Number
876.4680Why did this record match?
Product Code :
FFL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bard® Platinum Class™ Ureteroscopic 3 French Flat Wire Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.
Bard® Platinum Class™ Ureteroscopic 3 French High-Torque Helical Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.
Bard® Platinum Class™ Ureteroscopic 3 French Grasping Forceps is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.
Device Description
The Bard® Platinum Class™ 3 French Ureteroscopic Instrument product line consists of three separate instruments or stone dislodgers: the Flat Wire Stone Basket, the High-Torque Helical Stone Basket, and the Grasping Forceps. These instruments are each constructed of three main assemblies: a handle assembly, shaft assembly, and stone capture mechanism consisting of an expandable basket or grasping forceps assembly. Stone dislodgers (baskets or grasping forceps) may be used in the removal of renal and ureteral stones and calculi by inserting the stone basket or grasping forceps (while in a closed position) through the working channel of an endoscope and into the ureter or renal pelvis. The tip of the basket or forceps is advanced past the stone and the expandable basket or forceps is opened, manipulated and closed around the stone, thereby capturing it for removal. Once the stone has been captured, the basket or forceps should be partially closed to keep the stone from dislodging while the device and endoscope are being withdrawn. The devices have a 3 Fr. outer diameter shaft size and each is available in three different lengths, 70cm, 90cm and 115cm.
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