Cuattro, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Cuattro, LLC makes
Cuattro, LLC manufactures the CUATTRO UNOMD, a medical device designed for ultrasound-guided needle placement, and the CuattroDR, a disposable ultrasound probe cover system intended for single-patient use in diagnostic imaging procedures.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Cuattro Unomd Ref K093480
510(k) 510(k)CuattroDR Ref K161937
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Cuattro, LLC, initiated on 2019-10-15. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 15 Oct 2019 Z-1934-2020 Class II Terminated There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
Frequently asked questions
How many devices does Cuattro, LLC have in the registry?
The registry currently lists 2 devices for Cuattro, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cuattro, LLC's devices?
Among its 2 most recently registered devices, Cuattro, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Cuattro, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cuattro, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cuattro, LLC?
FDA recall records list 1 recall initiated by Cuattro, LLC, the most recent initiated on 2019-10-15. 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 Cuattro, LLC in the registry?
The most recently registered devices listed for Cuattro, LLC include CUATTRO UNOMD and CuattroDR.