Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list SPR Therapeutics with 7 510(k) clearances. The most recent is a 510(k) clearance dated Apr 14, 2026: SPRINT PNS System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 14, 2026 | SPRINT PNS SystemK240974 · SCN | 510(k) clearances |
| Jan 25, 2023 | SPRINT Peripheral Nerve Stimulation (PNS) SystemK223306 · NHI | 510(k) clearances |
| Oct 13, 2021 | SPRINT PNS SystemK211801 · NHI | 510(k) clearances |
| Jan 22, 2021 | SPRINT PNS SystemK202660 · NHI | 510(k) clearances |
| Jul 31, 2018 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer KitK181422 · NHI | 510(k) clearances |
| Jun 26, 2017 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator KitK170902 · NHI | 510(k) clearances |
| Jul 23, 2016 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 PacksK161154 · NHI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
