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Percutaneous Nephroscope System

by Karl Storz SE & CO. KG

510(k) K232370

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232370 Date1 May 2024ClearedStatusActive

Recalls

8 recalls · 8 ongoing · FDA

  • 8 recalls, same reason

    • Ongoing Z-3220-2024 FDA Class II initiated 23 Jul 2024
    • Ongoing Z-3218-2024 FDA Class II initiated 23 Jul 2024
    • Ongoing Z-3225-2024 FDA Class II initiated 23 Jul 2024
    • Ongoing Z-3221-2024 FDA Class II initiated 23 Jul 2024
    • Ongoing Z-3219-2024 FDA Class II initiated 23 Jul 2024
    • Ongoing Z-3222-2024 FDA Class II initiated 23 Jul 2024
    • Ongoing Z-3223-2024 FDA Class II initiated 23 Jul 2024
    • Ongoing Z-3224-2024 FDA Class II initiated 23 Jul 2024

    Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FGA
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Percutaneous Nephroscope System is a Kit, Nephroscope designed for endoscopic visualization and fragmentation of renal calculi (kidney stones) via percutaneous access. It combines a flexible nephroscope with irrigation, irrigation/aspiration, and fragmentation tools to facilitate stone removal during urological procedures. The system is intended for use in percutaneous nephrolithotomy (PCNL) and related interventions where direct visualization of the renal pelvis and calyces is required.

This system is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K232370) as a Class II medical device under product code FGA, falling under regulation 876.1500. It is intended for use in adult and pediatric patients over one month of age, with multiple nephroscope sizes and accessories included for compatibility with various anatomical and procedural requirements. The system is not MRI-safe and must be stored in accordance with manufacturer instructions to maintain sterility and functionality.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Percutaneous Nephroscope System used for?

    The Percutaneous Nephroscope System is designed for endoscopic visualization and fragmentation of renal calculi (kidney stones) during percutaneous nephrolithotomy (PCNL) and related urological interventions. It provides direct visualization of the renal pelvis and calyces, allowing for precise stone removal by combining a flexible nephroscope with irrigation, irrigation/aspiration, and fragmentation tools.

  • How is the Percutaneous Nephroscope System supplied and what are its sterility and reuse details?

    The system is supplied as a sterile, single-use device, ensuring safety and hygiene for each procedure. It is not intended for reuse, as single-use design maintains regulatory compliance and clinical best practices for infection control.

  • What age groups and anatomical variations does this system accommodate?

    The system is intended for use in both adult and pediatric patients over one month of age. It includes multiple nephroscope sizes and accessories to ensure compatibility with various anatomical structures and procedural requirements, enhancing flexibility for clinicians.

  • How should the Percutaneous Nephroscope System be stored?

    The system must be stored strictly according to the manufacturer’s instructions to preserve sterility and functionality. Improper storage could compromise device integrity or sterility, potentially affecting procedural outcomes or patient safety.

  • Is the Percutaneous Nephroscope System MRI-safe?

    No, the Percutaneous Nephroscope System is explicitly not MRI-safe. This means it should never be used or stored in an MRI environment, as exposure to magnetic fields could cause damage or pose safety risks to patients and staff.