FDA applicant

Nxthera, Inc.

Maple Grove, MN3 decisions2015–20181 recall

FDA records 3 decisions for Nxthera, Inc. (Maple Grove, MN) from 2015 to 2018: 3 510(k) clearances. All are in product code KNS (Unit, Electrosurgical, Endoscopic (With Or…). Its devices cite 4 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Nxthera, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2017

2015high 1 (2017) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Nxthera, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nxthera, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Nxthera”

FDA records each applicant name separately; these may or may not be the same firm.

Nxthera (A Boston Scientific Company) 2

Nxthera, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Nxthera”