Karl Storz Adult & Pediatric Nephroscope

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K940594 ↗

FDA Product Code

FGA

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• KARL STORZ Laryngoscopes and Accessories

  Class II

  FDA 510(k) K252624 Active Cleared 15 May 2026

• Ksea Dion-Gracia Set

  Class II

  FDA 510(k) K010785 Active Cleared 21 Aug 2001

• Karl Storz Slotted Whisker Arthroscopic Blade

  Class II

  FDA 510(k) K963029 Active Cleared 27 Nov 1996

• Storz SLX-F2 Storm Touch

  Class II

  FDA 510(k) K070579 Active Cleared 30 Aug 2007

• Karl Storz Micro-Instrument for Cochlear Implantation

  Class I

  FDA 510(k) K946332 Active Cleared 5 Jun 1995

• Flexible Video-Uretero-Renoscope System Open recall

  Class II

  FDA 510(k) K131369 Active Cleared 26 Nov 2013

See all devices from Karl Storz Endoscopy-America, Inc. →

• What types of procedures is the Karl Storz Adult & Pediatric Nephroscope primarily used for in clinical settings?

  The Karl Storz Adult & Pediatric Nephroscope is designed for visualizing and accessing the urinary collecting system, including the renal pelvis, calyces, and ureters. It is commonly used in urological interventions such as stone removal, biopsy, or relief of obstructions. Its rigid design and direct illumination allow for precise diagnostic and therapeutic procedures under direct visualization.

• Is the Karl Storz Adult & Pediatric Nephroscope intended for single-use or reusable applications, and how should it be handled?

  The Karl Storz Adult & Pediatric Nephroscope is explicitly supplied as a reusable medical instrument. Since it is intended for use in sterile surgical settings, it must be properly cleaned, disinfected, and sterilized between procedures to maintain safety and functionality. Reusability aligns with its classification as a Class II medical device under FDA regulation 876.1500.

• Are there multiple model variants available for the Karl Storz Adult & Pediatric Nephroscope, and if so, how does this affect clinical selection?

  Yes, multiple model variants of the Karl Storz Adult & Pediatric Nephroscope are available, as indicated by the diverse FEI numbers listed in the regulatory data. These variants likely cater to different patient sizes (adult vs. pediatric) or procedural requirements, allowing clinicians to select the appropriate size and configuration for specific cases. The exact specifications (e.g., diameters, working lengths) would determine clinical suitability.

• What regulatory pathway was followed for FDA clearance of the Karl Storz Adult & Pediatric Nephroscope, and what does this imply for its use?

  The device received 510(k) clearance under the Traditional pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it meets the same performance criteria as an existing, legally marketed nephroscope. The clearance was granted in 1994 and is classified under FDA regulation 876.1500, confirming its compliance with Class II medical device standards for urology and gastroenterology procedures.

• How should the Karl Storz Adult & Pediatric Nephroscope be stored to ensure its integrity and readiness for use?

  While the data does not specify storage conditions explicitly, as a reusable medical device intended for sterile surgical use, it should be stored in a clean, dry environment protected from contamination, moisture, and physical damage. Proper packaging (e.g., sterile barriers or sealed cases) and adherence to manufacturer guidelines for sterilization cycles (e.g., autoclave or ethylene oxide) are critical to maintaining its functionality and sterility between uses.