Sierra Scientific Instruments, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Sierra Scientific Instruments, Inc. makes
Sierra Scientific Instruments, Inc. manufactures motility visualization systems designed to assess gastrointestinal motility, including devices that combine optical and impedance-based imaging. These systems are used for evaluating intestinal function in clinical and research settings, providing real-time visualization of peristaltic activity.
The company’s products fall under FDA Class II regulatory classification and are authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Motility Visualization System Ref K031169
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Sierra Scientific Instruments, Inc., initiated on 2011-10-12. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 12 Oct 2011 Z-0135-2012 Unclassified (pre-2012) Terminated 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
Full distribution text
- 12 Oct 2011 Z-0135-2012 Unclassified (pre-2012) Terminated 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
Frequently asked questions
How many devices does Sierra Scientific Instruments, Inc. have in the registry?
The registry currently lists 2 devices for Sierra Scientific Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sierra Scientific Instruments, Inc.'s devices?
Among its 2 most recently registered devices, Sierra Scientific Instruments, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sierra Scientific Instruments, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sierra Scientific Instruments, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sierra Scientific Instruments, Inc.?
FDA recall records list 1 recall initiated by Sierra Scientific Instruments, Inc., the most recent initiated on 12 Oct 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Sierra Scientific Instruments, Inc. in the registry?
The most recently registered devices listed for Sierra Scientific Instruments, Inc. include MOTILITY VISUALIZATION SYSTEM and MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM.