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Protoco L Touch Colon Insufflator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132192

by Bracco Diagnostic, Inc.

Identifiers

510(k) Number
K132192 FDA 510(k)
FDA Product Code
FCX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Protoco L Touch Colon Insufflator is an Automatic Carbon-Dioxide Insufflator for Endoscope, designed to deliver and regulate carbon dioxide (CO₂) into the colon during endoscopic procedures. It automates the insufflation process, ensuring precise distention of the colon for improved visualization during imaging or diagnostic evaluations. This device is classified as a Class II medical device under FDA regulations, intended for use in gastroenterology and urology settings.

Supplied as a reusable device, the Protoco L Touch Colon Insufflator operates in controlled clinical environments such as endoscopy suites or CT colonography facilities. It requires storage at temperatures between 15° and 25°C and is approved under FDA 510(k) clearance (K132192). The device adheres to regulatory standards for automatic insufflation systems, ensuring compliance with 21 CFR Part 876.1500 for endoscopic accessories. No single-use or MRI safety considerations are specified in the regulatory data.

Frequently asked questions

What is the Protoco L Touch Colon Insufflator used for?

The Protoco L Touch Colon Insufflator is designed to automate the delivery and regulation of carbon dioxide (CO₂) into the colon during endoscopic procedures. This ensures controlled distention of the colon, improving visualization for diagnostic imaging or evaluations in gastroenterology and urology settings.

Is the Protoco L Touch Colon Insufflator reusable or single-use?

The Protoco L Touch Colon Insufflator is supplied as a reusable device. It is intended for use in controlled clinical environments such as endoscopy suites or CT colonography facilities, where proper cleaning and maintenance protocols can be followed.

What storage conditions are required for the Protoco L Touch Colon Insufflator?

The device should be stored at temperatures between 15°C and 25°C. Proper storage conditions help maintain its functionality and ensure compliance with regulatory standards for automatic insufflation systems.

Does the Protoco L Touch Colon Insufflator have any specific regulatory approvals?

The Protoco L Touch Colon Insufflator is approved under FDA 510(k) clearance with the clearance number K132192. It is classified as a Class II medical device and adheres to regulatory standards outlined in 21 CFR Part 876.1500 for endoscopic accessories.

Are there any special considerations for using this device in clinical settings?

The device is intended for use in controlled clinical environments such as endoscopy suites or CT colonography facilities. While it automates the insufflation process for precise colon distention, no specific MRI safety considerations or single-use requirements are mentioned in the regulatory data. Clinicians should follow standard protocols for cleaning and maintenance to ensure proper functionality and patient safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Protoco2l Touch | Bracco, Protoco2l | Bracco, PROTOCO2L TOUCH INSUFFLATOR | CTC Devices | CT Colonography - Bracco, PDF S510(k) Prernarket Notification Bracco Diagnostics Inc. PROTOCO L Touch ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bracco Diagnostic, Inc.

Sources (1)

  • FDA 510(k) K132192 24 fields · synced Oct 1, 2026