Endoscope and Accessories

• • Ongoing Z-1454-2026 FDA Class II ·initiated 11 Nov 2025

  Complaints of the ceramic tip of the resection sheath breaking have been received.

• • Ongoing Z-1437-2026 FDA Class II ·initiated 13 Sep 2024

  Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.

• • Ongoing Z-0351-2025 FDA Class II ·initiated 13 Sep 2024

  Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.

• • Terminated Z-0696-2018 FDA Class II ·initiated 18 Aug 2017

  Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Cracking, chipping, missing pieces, and delamination of the adhesive have also been reported. In one case, a fragment of the adhesive was detected inside a patient's urethra during a procedure and was retrieved without injury to the patient. The manufacturer, Olympus Winter & lbe GmbH ("OWi") has determined that adhesive can be dislodged during the intended use of the cystoscopy bridge or working insert, e.g., when inserting an instrument through the working channel. As a result, a fragment of the adhesive may fall inside the patient's bladder, urethra or uterus and would need to be retrieved, extending the length of the procedure or requiring additional surgical treatment. The adhesive is used to seal gaps inside the working channel of the cystoscopy bridges and working inserts. In 2013, the adhesive used until then was discontinued and had to be replaced. Current investigations revealed that the durability of the new adhesive is insufficient

• • Terminated Z-2629-2017 FDA Class II ·initiated 19 Apr 2017

  Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.

• • Terminated Z-1163-2010 FDA Unclassified (pre-2012) ·initiated 8 Feb 2010 ·via K790071, on the same 510(k)

  weak weld seams

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K790071 ↗

FDA Product Code

GCP

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Olympus Direct Bilirubin Reagent

  Class II

  FDA 510(k) K924963 Active Cleared 30 Nov 1992

• Olympus Chloride Reagent, Modification

  Class II

  FDA 510(k) K934136 Active Cleared 5 Nov 1993

• Resectoscope Sheath

  Class II

  FDA 510(k) K931994 Active Cleared 17 Feb 1994

• Olympus Measuring Devices

  Class II

  FDA 510(k) K933717 Active Cleared 2 Nov 1993

• Sterile Disposable Cytology Brush

  Not classified

  FDA 510(k) K802187 Active Cleared 10 Sep 1980

• Olympus Infant Resectoscope and Accessories

  Class II

  FDA 510(k) K904940 Active Cleared 13 Jan 1992

See all devices from Olympus Corp. →

• Are these Olympus endoscopes designed for single-use or reusable applications in clinical settings?

  These Olympus endoscopes and accessories are reusable medical devices, requiring proper sterilization and maintenance as outlined in the manufacturer’s guidelines. They are intended for repeated use in clinical settings like gastroenterology and urology, where durability and repeated disinfection are necessary for diagnostic and therapeutic procedures.

• What types of procedures are these endoscopes and accessories primarily used for?

  These devices are classified under the nomenclature for gastrointestinal and urological diagnostic and therapeutic procedures, meaning they are designed for internal visual examinations and interventions within the digestive and urinary tracts. This includes procedures like colonoscopies, upper GI endoscopies, and urological evaluations, though the exact indications are determined by clinical practice and not by the regulatory submission details.

• How many model references are included in this registration, and what does this mean for compatibility?

  This registration includes multiple model references (e.g., 3009217531, 3007388124, etc.), indicating a range of Olympus endoscope systems and accessories are covered. This ensures compatibility with various Olympus endoscope platforms, allowing clinicians to select the appropriate model for their specific diagnostic or therapeutic needs in gastroenterology or urology.

• What regulatory pathway was followed for FDA clearance of these endoscopes, and what does that imply about their safety and performance?

  These endoscopes were cleared via the FDA 510(k) pathway, specifically under the classification 876.1500 (Ac-Powered Endoscope, Flexible, Diagnostic and Therapeutic). The clearance type is labeled as *Traditional*, meaning the manufacturer demonstrated that their device is *substantially equivalent* to a legally marketed predicate device. This implies the device meets FDA safety and performance standards for its intended uses in gastroenterology and urology.

• Are there any special storage requirements for these reusable endoscopes and accessories?

  While the provided data does not specify storage conditions, reusable endoscopes like these typically require proper cleaning, disinfection, and storage to prevent contamination and maintain functionality. Manufacturers usually provide detailed guidelines for storage environments (e.g., temperature, humidity) and handling to ensure longevity and sterility between uses. Always follow Olympus Corp.’s maintenance protocols for optimal performance.