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510(k) Data Aggregation
K Number
DEN000002Device Name
UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
Manufacturer
UROSURGE, INC.
Date Cleared
2000-02-09
(13 days)
Product Code
NAM
Regulation Number
876.5310Why did this record match?
Applicant Name (Manufacturer) :
UROSURGE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992391Device Name
UROSURGE SPIRALFLO URETERAL STENT
Manufacturer
UROSURGE, INC.
Date Cleared
1999-08-18
(30 days)
Product Code
FAD
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
UROSURGE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UroSurge SpiraFlo Ureteral Stent has no holes in the walls along the side of the stent. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. These stents must not remain indwelling for more than 29 days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
Device Description
The UroSurge SpiraFlo Ureteral Stent has no holes in the walls along the side of the stent. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. These stents must not remain indwelling for more than 29 days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
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K Number
K981489Device Name
UROSURGE SPIRASTENT PLUS URETERAL STENT
Manufacturer
UROSURGE, INC.
Date Cleared
1998-05-29
(32 days)
Product Code
FAD
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
UROSURGE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UroSurge SpiraStent Plus™ Ureteral Stent, has a reinforcing filament which increases its tensile strength, thereby minimizing the probability of the stent breaking during removal. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. The duration of the placement of these stents must not remain indwelling more than twenty-nine (29) days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
Device Description
The UroSurge SpiraStent Plus™ Ureteral Stent, has a reinforcing filament which increases its tensile strength, thereby minimizing the probability of the stent breaking during removal.
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K Number
K981491Device Name
UROSURGE FILASTENT URETERAL STENT
Manufacturer
UROSURGE, INC.
Date Cleared
1998-05-29
(32 days)
Product Code
FAD
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
UROSURGE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UroSurge FilaStent TM Ureteral Stent, has a reinforcing filament which increases its tensile strength, thereby minimizing the probability of the stent breaking during removal. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. The duration of the placement of these stents must not remain indwelling more than twenty-nine (29) days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
Device Description
UroSurge FilaStent™ Ureteral Stent
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