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Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Anorectal Pressure Catheter, Model GIA-8500

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022023

by Clinical Innovations, Inc.

Identifiers

510(k) Number
K022023 FDA 510(k)
FDA Product Code
KLA FDA 510(k)
Models / Variants
Gie-8500 FDA 510(k)
Compass Ano-Rectal Pressure Catheter FDA 510(k)
Model Gia-8500 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1725 FDA 510(k)
Regulation Number
876.1725 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Compass Esophageal Pressure Catheter, Model GIE-8500, and Compass Anorectal Pressure Catheter, Model GIA-8500, are designed for measuring intraluminal pressure in the esophagus and anorectal regions, respectively. These catheters are classified as monitors for esophageal and anorectal motility, enabling assessment of gastrointestinal function during manometry studies. They provide precise pressure readings to evaluate motility disorders, reflux, and sphincter function. The devices are intended for use in clinical settings where gastrointestinal motility testing is required.

These catheters are supplied as single-use devices and are regulated under FDA 510(k) clearance (K022023) as substantially equivalent to predicate devices. They are intended for use in gastroenterology and urology procedures, adhering to regulatory standards outlined in 876.1725. The devices are not MRI-safe and must be stored according to manufacturer guidelines to maintain sterility and functionality. No additional regulatory approvals beyond the stated 510(k) clearance are implied.

Frequently asked questions

What are the Compass Esophageal Pressure Catheter (Model GIE-8500) and Anorectal Pressure Catheter (Model GIA-8500) used for?

These catheters are designed to measure intraluminal pressure in the esophagus and anorectal regions, respectively. They enable clinicians to assess gastrointestinal motility, evaluate reflux, and evaluate sphincter function during manometry studies. This helps diagnose motility disorders and other conditions affecting gastrointestinal function.

Are the Compass catheters single-use or reusable?

The Compass Esophageal Pressure Catheter (Model GIE-8500) and Anorectal Pressure Catheter (Model GIA-8500) are supplied as single-use devices. This ensures sterility and reduces the risk of cross-contamination between patients, adhering to clinical best practices for invasive medical devices.

How should these catheters be stored to maintain sterility and functionality?

The catheters must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Proper storage typically involves keeping them in a sealed, sterile packaging until use and avoiding exposure to extreme temperatures or moisture. Always follow the instructions provided by Clinical Innovations, Inc.

Are these catheters MRI-safe?

No, the Compass Esophageal and Anorectal Pressure Catheters are explicitly stated as not MRI-safe. This means they should not be used or placed near MRI equipment, as the magnetic fields could cause damage or pose safety risks.

What regulatory clearance do these catheters hold?

The Compass catheters hold FDA 510(k) clearance under the reference number K022023, classified as substantially equivalent to predicate devices. This clearance confirms they meet regulatory standards for use in gastroenterology and urology procedures under 876.1725. No additional regulatory approvals beyond this are implied.

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: Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano ..., Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano ..., Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano ..., foiadocs.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Clinical Innovations, Inc.

Sources (1)

  • FDA 510(k) K022023 24 fields · synced Oct 1, 2026