Solar Anorectal Manometry Catheter (Model K1210AC-L-2212)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K234107 FDA 510(k)
- FDA Product Code
- KLA 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 Solar Anorectal Manometry Catheter (Model K1210AC-L-2212) is a diagnostic device classified as a monitor for esophageal and anorectal motility, designed to measure pressures within the anal canal and rectum. It provides quantitative data on sphincter function, rectal compliance, and motility patterns, aiding in the evaluation of conditions such as fecal incontinence, constipation, and neurogenic bowel disorders.
This catheter is intended for single-use in clinical settings such as gastroenterology and urology departments, where it is connected to a manometry system for real-time pressure recording. Supplied sterile and packaged for one-time use, it adheres to FDA 510(k) clearance and EU MDR compliance. The device is non-MRI safe and requires proper storage under controlled conditions to maintain sterility and functionality.
Frequently asked questions
What clinical conditions is the Solar Anorectal Manometry Catheter primarily used to evaluate?
The Solar Anorectal Manometry Catheter is designed to assess conditions related to anal and rectal function, such as fecal incontinence, constipation, and neurogenic bowel disorders. It measures pressures in the anal canal and rectum, providing quantitative data on sphincter function, rectal compliance, and motility patterns to aid in diagnosing these conditions.
Is the Solar Anorectal Manometry Catheter intended for reuse, or is it meant for single-use only?
The device is explicitly supplied sterile and packaged for single-use in clinical settings. This ensures patient safety and maintains the integrity of measurements, as reuse could compromise sterility and accuracy.
How should the Solar Anorectal Manometry Catheter be stored to preserve its sterility and functionality?
The catheter must be stored under controlled conditions to maintain sterility and functionality. Since it is single-use and sterile upon packaging, it should remain unopened until use and kept in a clean, dry environment away from direct sunlight or extreme temperatures.
Can this catheter be used with any manometry system, or is it compatible only with specific equipment?
The Solar Anorectal Manometry Catheter is intended for connection to a manometry system for real-time pressure recording, but compatibility depends on the system’s specifications. While the device itself is designed for diagnostic use in anorectal motility assessment, verification with your existing equipment is recommended to ensure proper integration.
What regulatory pathways does the Solar Anorectal Manometry Catheter follow, and what does that mean for purchasing or use?
The catheter follows FDA 510(k) clearance and EU MDR compliance, meaning it has undergone regulatory review to demonstrate safety and effectiveness for its intended diagnostic use. This ensures it meets U.S. and European standards for medical devices in gastroenterology and urology settings, providing confidence in its clinical application.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K234107 | Class II | Active |
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Manufacturer
- Manufacturer
- Laborie Medical Technologies Corp.
- FDA Applicant
- Laborie Medical Technologies, Corp.
Sources (2)
- FDA 510(k) K234107 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026