Nxthera, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Nxthera, Inc. makes
Nxthera, Inc. manufactures single-use percutaneous radio-frequency ablation probe cannulas designed for medical procedures. These devices are primarily used in the Rezum System, which employs radio-frequency energy to treat benign prostatic hyperplasia (BPH).
The company’s products fall under FDA Class II regulation and are listed in the FDA’s 510(k) and UDI registries. Nxthera, Inc. is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
Rezum System Ref K150786
Regimes: 510(k) Registry: 510(k)Rezum System Ref K180237
Regimes: 510(k) Registry: 510(k)Rezum System Ref K160417
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 947824194
- [email protected]
- Phone
- 6123969849
FDA recalls
FDA recall records list 1 recall initiated by Nxthera, Inc., initiated on 2017-07-28. 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 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 28 Jul 2017 Z-0262-2018 Class II Terminated Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments.
Frequently asked questions
How many devices does Nxthera, Inc. have in the registry?
The registry currently lists 5 devices for Nxthera, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nxthera, Inc.'s devices?
Among its 5 most recently registered devices, Nxthera, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Nxthera, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Nxthera, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Nxthera, Inc.?
FDA recall records list 1 recall initiated by Nxthera, Inc., the most recent initiated on 28 Jul 2017. 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 Nxthera, Inc. in the registry?
The most recently registered devices listed for Nxthera, Inc. include rezum D2201, Rezūm Accessory Kit D2202 and Rezum System.