Cleared Traditional

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)

K240319 · Pro-Med Instruments GmbH · Neurology
Apr 2024
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K240319 is an FDA 510(k) clearance for the DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040), a Holder, Head, Neurosurgical (skull Clamp) (Class II — Special Controls, product code HBL), submitted by Pro-Med Instruments GmbH (Freiburg, DE). The FDA issued a Cleared decision on April 24, 2024, 82 days after receiving the submission on February 2, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K240319 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2024
Decision Date April 24, 2024
Days to Decision 82 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBL — Holder, Head, Neurosurgical (skull Clamp)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4460

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