Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list OTU Medical with 5 510(k) clearances. The most recent is a 510(k) clearance dated Sep 29, 2023: WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiS….
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.
| Sep 29, 2023 | WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical TabletK231702 · FAJ | 510(k) clearances |
| Jun 16, 2022 | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image SystemK220399 · EOQ | 510(k) clearances |
| Apr 13, 2022 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image SystemK212202 · FAJ | 510(k) clearances |
| Jul 22, 2021 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image SystemK210579 · FGB | 510(k) clearances |
| Aug 14, 2018 | WiScope Digital Endoscope SystemK181977 · FGB | 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
