HAE
- Product code
- HAE
- Device name
- Rongeur, Manual
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4840
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 36 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242759 | 2025-06-06 | Geister Medizin Technik GmbH | Geister K-Rex rongeurs |
Official FDA classification page: HAE
Classification and pathway per current FDA publications. Data from openFDA (CC0).