Karl Storz Fixed Magnification Telescope / Karl Storz Variable Magnification Telescope

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

510(k) Number

K935278 ↗

FDA Product Code

FAJ

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. →

• Are these telescopes designed for single-use or reusable applications, and how should I determine which model fits my needs?

  The Karl Storz Fixed and Variable Magnification Telescopes are available in both single-use and reusable configurations, depending on the specific model. The description explicitly states they are intended for *single-use or reusable* applications, so you should check the packaging or consult the manufacturer’s documentation for each model to confirm its designated use. Reusable models would require proper cleaning, sterilization, and maintenance procedures, while single-use models are intended for one-time procedures only.

• What medical specialties are these telescopes primarily used in, and how does that translate to clinical applications?

  These telescopes are designed for urology and gastroenterology, as noted in the advisory committee and medical specialty descriptions. Clinically, this means they are used for magnified visualization of internal anatomical structures in procedures like cystoscopy (bladder examination) or upper gastrointestinal endoscopy, aiding in precise examination and procedural guidance in those specialties.

• How should I store these telescopes to ensure they remain functional and safe for use?

  The device description emphasizes that proper storage is required to maintain functionality. While specific storage conditions (e.g., temperature, humidity) aren’t detailed here, standard endoscopic equipment guidelines apply—typically, telescopes should be stored in a clean, dry environment, away from direct sunlight or extreme temperatures. For reusable models, follow the manufacturer’s instructions for cleaning and storage after use to prevent damage or contamination.

• Are these telescopes compatible with standard endoscopic systems, and what does that mean for my existing setup?

  Yes, the description confirms these telescopes are compatible with standard endoscopic systems. This means they can be integrated into your existing equipment setup without requiring additional adapters or modifications, assuming your system supports rigid cystoscopy. Compatibility is critical for seamless use in urology or gastroenterology procedures, ensuring the telescopes connect properly to your camera and light source.

• How do I know if a specific model is sterile or non-sterile, and why does that matter?

  Sterility status varies by model, as the description notes they are supplied sterile or non-sterile based on specifications. This distinction matters because sterile models are ready for immediate use in procedures without additional processing, while non-sterile models would require sterilization (e.g., autoclaving or ethylene oxide) before use. Always verify the packaging or consult the manufacturer’s documentation to confirm sterility before use, as improper handling could compromise patient safety.