Model SC-6 Flexible Sigmoidoscope

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

Full name

Model Sc-6, Flexible Siamoidoscope

510(k) Number

K812965 ↗

FDA Product Code

FAM

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• Ultravue Blended Bifocal Lens

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• Ao Flexible Laryngoscope, #ls-7

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  FDA 510(k) K802331 Active Cleared 10 Oct 1980

• Aoi Universal Ultrasonic Handpiece

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  FDA 510(k) K950880 Active Cleared 26 May 1995

• Phaco Tip

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See all devices from American Optical Corp. →

• What is the primary use of the Model SC-6 Flexible Sigmoidoscope?

  The Model SC-6 Flexible Sigmoidoscope is designed for visual examination of the sigmoid colon and lower gastrointestinal tract. It provides illumination and access for direct observation of internal structures, aiding in diagnostic procedures such as polyp detection, mucosal inspection, and biopsy guidance. This makes it a critical tool in gastroenterology and urology for identifying abnormalities and planning further treatment.

• Is the Model SC-6 Flexible Sigmoidoscope reusable or single-use?

  The Model SC-6 Flexible Sigmoidoscope is a reusable medical instrument. To ensure safety and functionality between procedures, it requires proper sterilization and maintenance. Reusability is common for endoscopes in clinical settings, provided rigorous cleaning and sterilization protocols are followed to prevent cross-contamination and maintain device integrity.

• What regulatory approval does the Model SC-6 Flexible Sigmoidoscope hold?

  The Model SC-6 Flexible Sigmoidoscope holds FDA 510(k) clearance under the reference number K812965. It was classified as substantially equivalent to a predicate device and reviewed by the Gastroenterology and Urology (GU) Advisory Committee. This clearance confirms its compliance with U.S. regulatory standards for flexible sigmoidoscopes, ensuring it meets established safety and performance requirements for professional clinical use.

• How is the Model SC-6 Flexible Sigmoidoscope supplied, and what accessories are included?

  The Model SC-6 Flexible Sigmoidoscope is supplied as a reusable device intended for professional use in clinical environments. While the exact accessories included are not detailed in the provided data, flexible sigmoidoscopes typically come with components such as control handles, light sources, and insertion tubes. For precise details on included accessories, refer to the manufacturer’s instructions or product packaging, as these may vary slightly by batch or configuration.

• What maintenance or sterilization procedures are required for the Model SC-6 Flexible Sigmoidoscope?

  Since the Model SC-6 Flexible Sigmoidoscope is reusable, it must undergo thorough sterilization between uses to prevent infection and ensure functionality. Standard procedures include high-level disinfection followed by sterilization using methods such as autoclaving or chemical sterilization, depending on manufacturer guidelines. Proper cleaning, inspection for damage, and adherence to sterilization protocols are essential to maintain the device’s performance and safety for repeated clinical use.