DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
510(k) K240319
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240319 | Date24 Apr 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HBL
- Models / Variants
- FDA applicant
- Pro Med Instruments GmbH
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4460
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Doro Lucent Skull Clamp is a neurosurgical skull clamp, also known as a holder, head, neurosurgical. It is used in neurosurgical procedures involving intraoperative X-ray based Angiography, CT or X-Ray imaging. The device features rounded contours and the absence of straight surfaces, which ensure superior imaging results. The Doro Lucent Skull Clamp is available in two versions: the standard model (1101.001) and the pediatric set (1101.040).
The Doro Lucent Skull Clamp is supplied in two models, with the standard model (1101.001) and the pediatric set (1101.040) available. The device has been authorized with an FDA 510K clearance. The manufacturer, Pro-Med Instruments GmbH, is based in Freiburg, Germany. The device is classified as a class 2 device, with a regulation number of 882.4460.