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., part of Olympus CorporationLabelled 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 13, 2026, FDA's public records list Spiration, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Nov 20, 2017: B7 2C Occlusion Balloon.
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.
| Date | Record | Source |
|---|---|---|
| Nov 20, 2017 | B7 2C Occlusion BalloonK171492 · EOQ | 510(k) clearances |
| May 11, 2017 | Active Needle Endoscopic Treatment (ANET) Electrosurgical ApplicatorK170990 · GEI | 510(k) clearances |
| Feb 9, 2017 | PeriFLEXK162611 · EOQ | 510(k) clearances |
| Feb 19, 2016 | ViziShot FLEXK152922 · KTI | 510(k) clearances |
| Apr 24, 2015 | Flexible 19G EBUS NeedleK142909 · EOQ | 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
