K241883
- 510(k) number
- K241883
- Device name
- DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)
- Applicant
- Pro Med Instruments GmbH DE
- Product code
- HBL — Holder, Head, Neurosurgical (Skull Clamp)
- Decision date
- 2024-07-26
- Date received
- 2024-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K241883.pdf
Official FDA record: K241883
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.