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K Number
K001563
Device 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
876.4680
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 876.4680 Ureteral stone dislodger.

(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.