Colonoscope Guiding Tube Device

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

510(k) Number

K884857 ↗

FDA Product Code

FDF

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What clinical specialties is this device primarily intended for, and how does it assist during procedures?

  This device is designed for use in gastroenterology and urology procedures. It serves as a flexible accessory to aid in the insertion and navigation of a colonoscope, improving maneuverability and support. This helps enhance visualization and access within the colon, making it easier to perform diagnostic and therapeutic interventions.

• Is this device reusable, or is it meant for single-use only? How does that affect its use in clinical settings?

  The device is explicitly single-use only, meaning it is intended for one-time use in clinical settings. This design reduces the risk of cross-contamination and ensures sterility for each procedure, which is critical in gastroenterology and urology where infection control is paramount.

• How is the device supplied, and what should clinicians expect when receiving a shipment?

  The device is supplied sterile, ready for immediate use after opening. Since it is single-use, clinicians should expect each unit to be individually packaged and sealed to maintain sterility until deployment. No additional preparation or sterilization is required before use.

• Are there different sizes or models available for this device, and if so, how might a clinician determine the right fit?

  The provided data does not specify distinct sizes or models for this device, but it is categorized under flexible colonoscope accessories. Clinicians should refer to the manufacturer’s instructions or consult with Mill-Rose Laboratory to ensure compatibility with their specific colonoscope and procedural needs.

• What regulatory pathway was followed for this device, and how does that impact its use in the U.S.?

  This device received FDA 510(k) clearance (K884857) under the substantial equivalence pathway, meaning it was deemed comparable to a legally marketed predicate device. This clearance confirms its compliance with FDA regulations (21 CFR 876.1500) and allows it to be legally marketed and used in the U.S. for its intended purposes in gastroenterology and urology.