HBL
- Product code
- HBL
- Device name
- Holder, Head, Neurosurgical (Skull Clamp)
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4460
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 50 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250423 | 2025-11-06 | Medical Bees GmbH | mb-FIX Cranial Stabilization Systems | |
| K241883 | 2024-07-26 | Pro Med Instruments GmbH | DORO Sterile Disposable Skull Pins Stainless Steel, … | FDA |
| K240319 | 2024-04-24 | Pro Med Instruments GmbH | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skul… |
Official FDA classification page: HBL
Classification and pathway per current FDA publications. Data from openFDA (CC0).