Nxthera, Inc.
Maple Grove, MN, US
Nxthera, Inc. appears in FDA device records in Maple Grove, MN. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Nxthera, Inc. between 2015 and 2018. The busiest year on record is 2015, with 1. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0262-2018 | Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to 50 years of age with a prostate volume greater than or equal to 30cm3 and less than or equal to 80cm3. The Rezum System is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe. | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain