Cleared Traditional

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)

K193438 · Pro-Med Instruments GmbH · Neurology
Jun 2020
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K193438 is an FDA 510(k) clearance for the DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium), 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 June 2, 2020, 174 days after receiving the submission on December 11, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K193438 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2019
Decision Date June 02, 2020
Days to Decision 174 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

Similar Devices — HBL Holder, Head, Neurosurgical (skull Clamp)

All 49
mb-FIX Cranial Stabilization Systems
K250423 · Medical Bees GmbH · Nov 2025
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)
K241883 · Pro-Med Instruments GmbH · Jul 2024
DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
K240319 · Pro-Med Instruments GmbH · Apr 2024
DORO QR3 Headrest System (Aluminum)
K203505 · Pro-Med Instruments GmbH · Mar 2021
DORO LUCENT? iXI and iMRI Headrest System
K191740 · Pro-Med Instruments GmbH · Feb 2020
Arcus Head Fixation Frame
K191701 · Mri Interventions, Inc. · Nov 2019

More from Pro-Med Instruments GmbH

View all
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)
K241883 · HBL · Jul 2024
DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
K240319 · HBL · Apr 2024
DORO QR3 Headrest System (Aluminum)
K203505 · HBL · Mar 2021
DORO LUCENT? iXI and iMRI Headrest System
K191740 · HBL · Feb 2020
DORO QR3 XTom Headholder System
K191979 · HBL · Oct 2019