# Giranel Guiding Sheath Set (K262674): 510(k) cleared for Kossel Medtech (Suzhou) Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 36/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262674 |
| Device | Giranel Guiding Sheath Set |
| Applicant | Kossel Medtech (Suzhou) Co., Ltd. |
| Specialty / panel | Cardiovascular |
| Product code | DYB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-30 |
| Decision date | 2026-10-15 |
| Review time (days) | 77 |
| Third-party review | No |
| Applicant location | Suzhou New District, CN |

## Why this score
- Fast 77-day review: this device is a strong predicate for similar products.
- Posted 20 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262674). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.