Cleared Special

K241883 - DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00) (FDA 510(k) Clearance)

Also includes:
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)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241883 · Pro-Med Instruments GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
28d
Days
Class 2
Risk

K241883 is an FDA 510(k) clearance for the DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00). Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Pro-Med Instruments GmbH (Freiburg, DE). The FDA issued a Cleared decision on July 26, 2024 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pro-Med Instruments GmbH devices

Submission Details

510(k) Number K241883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2024
Decision Date July 26, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.