Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled 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 Kossel Medtech (Suzhou) Co., Ltd. with 7 510(k) clearances. The most recent is a 510(k) clearance dated Oct 15, 2026: Giranel Guiding Sheath Set.
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 |
|---|---|---|
| Oct 15, 2026 | Giranel Guiding Sheath SetK262674 · DYB | 510(k) clearances |
| Sep 16, 2026 | NC PTA Balloon Dilatation CatheterK254212 · LIT | 510(k) clearances |
| Dec 20, 2023 | HP PTA Balloon Dilatation CatheterK231402 · LIT | 510(k) clearances |
| Dec 14, 2022 | PTA Balloon Dilatation CatheterK221245 · LIT | 510(k) clearances |
| Jan 7, 2022 | Selebrek PTCA Balloon Dilatation CatheterK211349 · LOX | 510(k) clearances |
| Jul 2, 2021 | Selethru(TM) NC PTCA Balloon Dilatation CatheterK211393 · LOX | 510(k) clearances |
| Nov 26, 2018 | Selethru PTCA Balloon Dilatation CatheterK182699 · LOX | 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
