FDA applicant

Spr Therapeutics, Inc.

Cleveland, OH7 decisions2016–20260 recalls

FDA records 7 decisions for Spr Therapeutics, Inc. (Cleveland, OH) from 2016 to 2026: 7 510(k) clearances. Most are in product codes NHI (Stimulator, Nerve, Electrical, Percutaneous…) and GZF (Stimulator, Peripheral Nerve, Implanted (Pain…). Its devices cite 10 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Spr Therapeutics, LLC”.

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

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

1in 2023

2016high 2 (2021) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Spr Therapeutics, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Spr Therapeutics, 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?