SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET

• 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

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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