Motility Visualization System
by Sierra Scientific Instruments, Inc.
510(k) K031169
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031169 | Date12 Dec 2003 | StatusActive |
Recalls
-
- Terminated Z-0135-2012
The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test, the Field Safety Corrective Action (FSCA) Committee was convened. As a result of the data discussed during this meeting, a decision was made to voluntarily recall this product, and cease its further commercialization or distr
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FFX
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1725
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Motility Visualization System is a medical device classified under Gastrointestinal Motility (Electrical) systems. It is designed to visualize and analyze gastrointestinal motility by measuring electrical activity and mechanical contractions in the digestive tract, aiding in the assessment of motility disorders.
This system is intended for use in clinical settings such as gastroenterology and urology. It is a reusable device, regulated under 21 CFR 876.1725 and granted FDA 510(k) clearance (K031169) as substantially equivalent to a predicate device. No specific sterility or MRI safety information is provided in the data, and its operation relies on electrical impedance measurements.
Other devices from Sierra Scientific Instruments, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical specialties primarily use the Motility Visualization System, and why is it relevant to them?
The Motility Visualization System is primarily used in gastroenterology and urology clinics. It helps visualize and analyze gastrointestinal motility by measuring electrical activity and mechanical contractions in the digestive tract, which is critical for diagnosing motility disorders like gastroparesis, irritable bowel syndrome, or urological conditions affecting bladder function. The system aids specialists in assessing how well the digestive or urinary tract moves contents, guiding treatment decisions.
Is the Motility Visualization System single-use or reusable, and what does that mean for maintenance?
The Motility Visualization System is a reusable device, meaning it is designed for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. Since it relies on electrical impedance measurements and is not sterile by design, facilities must follow manufacturer guidelines for reprocessing to ensure accuracy and safety between uses. This approach reduces waste and cost compared to single-use alternatives.
How is the Motility Visualization System regulated, and what does that mean for purchasing or clinical use?
The system is regulated under 21 CFR 876.1725 as a Gastrointestinal Motility (Electrical) device and holds FDA 510(k) clearance (K031169), confirming it is substantially equivalent to a predicate device. This means it has undergone FDA review for safety and effectiveness, ensuring it meets regulatory standards for clinical use. Purchasers should verify compliance with the manufacturer’s instructions and facility protocols to maintain regulatory adherence.
Are there different models or sizes available for the Motility Visualization System, and how might that affect selection?
The data lists multiple FEI numbers (e.g., 3010381606, 3012480535), which typically correspond to different configurations, accessories, or software versions of the system rather than physical sizes. These variations may include differences in electrode sets, software algorithms, or compatibility with specific anatomical regions (e.g., esophageal, gastric, or colonic studies). Clinicians should confirm with the manufacturer which model aligns with their diagnostic needs, such as patient population or specific motility assessments.
Does the Motility Visualization System require any special storage conditions, and why is that important?
The provided data does not specify sterility requirements or special storage conditions for the Motility Visualization System, but as a reusable device, it should be stored in a clean, dry environment to prevent contamination or damage. Since it involves electrical components and software, it should also be protected from extreme temperatures, humidity, or physical impacts that could affect performance. Proper storage ensures the system remains accurate and functional for repeated clinical use.