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ProtectiScope CS Colonoscope, Non-Intrapull

by Stryker GI

510(k) K081004

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK081004 Date2 May 2008ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FDF
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ProtectiScope CS Colonoscope, Non-Intrapull is a flexible colonoscope designed for visualization and therapeutic access to the lower gastrointestinal (GI) tract. It is classified as a flexible/rigid colonoscope and accessory device, intended for diagnostic and procedural use in gastroenterology and urology. The device features a software-controlled system to enhance maneuverability and control during colonoscopy procedures.

This device is supplied as a reusable system comprising a control unit, flexible insertion tube, control body, and umbilicus, with a disposable sleeve for the insertion tube to ensure single-use hygiene. It is regulated under FDA 510(k) clearance (K081004) and is intended for use in clinical settings where sterile or aseptic conditions are maintained. The device is not MRI-safe, and its use adheres to standard infection control protocols. No additional regulatory approvals beyond the stated 510(k) clearance are implied.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ProtectiScope CS Colonoscope, Non-Intrapull used for?

    The ProtectiScope CS Colonoscope, Non-Intrapull is designed for visualization and therapeutic access to the lower gastrointestinal (GI) tract. It is intended for both diagnostic and procedural use in gastroenterology and urology, allowing clinicians to perform colonoscopies and related interventions with enhanced control and maneuverability.

  • How is the ProtectiScope CS Colonoscope, Non-Intrapull supplied?

    This device is supplied as a reusable system, including a control unit, flexible insertion tube, control body, and umbilicus. To maintain hygiene, it comes with a disposable sleeve for the insertion tube, ensuring single-use protection for each procedure.

  • Is the ProtectiScope CS Colonoscope, Non-Intrapull sterile?

    The device is intended for use in clinical settings where sterile or aseptic conditions are maintained. While the reusable components are cleaned and processed according to standard infection control protocols, the disposable sleeve ensures single-use hygiene for the insertion tube.

  • Can the ProtectiScope CS Colonoscope, Non-Intrapull be reused?

    Yes, the reusable components of the ProtectiScope CS Colonoscope, Non-Intrapull—such as the control unit, insertion tube, control body, and umbilicus—are designed for repeated use. However, the insertion tube must be used with a new disposable sleeve for each procedure to ensure single-use hygiene and infection control.

  • What regulatory approval does the ProtectiScope CS Colonoscope, Non-Intrapull hold?

    The ProtectiScope CS Colonoscope, Non-Intrapull holds FDA 510(k) clearance under the reference number K081004. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets applicable regulatory requirements for flexible/rigid colonoscopes and accessories.