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

FDA 510(k) K193438 · Pro Med Instruments GmbH

Substantially Equivalent

510(k) numberK193438

Submission

Device name
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
Applicant
Pro Med Instruments GmbH
Freiburg, DE
Received
December 11, 2019
Decision date
June 2, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBL – Holder, Head, Neurosurgical (Skull Clamp)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4460
Specialty
Neurology

Other 510(k)s with product code HBL

510(k)DeviceApplicantDecision
K250423mb-FIX Cranial Stabilization SystemsHBL · Traditional Medical Bees GmbH11/06/2025SE
K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO…HBL · Special Pro Med Instruments GmbH07/26/2024SE
K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)HBL · Traditional Pro Med Instruments GmbH04/24/2024SE
K203505DORO QR3 Headrest System (Aluminum)HBL · Traditional Pro Med Instruments GmbH03/29/2021SE
K191740DORO LUCENT® iXI and iMRI Headrest SystemHBL · Traditional Pro Med Instruments GmbH02/21/2020SE
K191701Arcus Head Fixation FrameHBL · Traditional Mri Interventions, Inc.11/15/2019SE
K191979DORO QR3 XTom Headholder SystemHBL · Traditional Pro Med Instruments GmbH10/22/2019SE
K163322TZ SKULL PIN AdultHBL · Traditional Tz Medical, Inc.02/23/2017SE
K142238MAYFIELD Skull ClampHBL · Traditional Integra LifeSciences Corporation11/24/2014SE
K141950HFD100 Rocker Arm AccessoryHBL · Special Imris, Inc.09/04/2014SE

More from Imris, Inc.

510(k)DeviceDecision
K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO…HBL · Special 07/26/2024SE
K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)HBL · Traditional 04/24/2024SE
K203505DORO QR3 Headrest System (Aluminum)HBL · Traditional 03/29/2021SE
K191740DORO LUCENT® iXI and iMRI Headrest SystemHBL · Traditional 02/21/2020SE
K191979DORO QR3 XTom Headholder SystemHBL · Traditional 10/22/2019SE
K063494Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsHBL · Traditional 05/21/2007SE
K070997Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables…GEI · Traditional 05/16/2007SE
K032331Doro Radiolucent Headrest System and Horseshoe Headrests,And Non-Radiolucent J-Arm…HBL · Traditional 11/20/2003SE
K001808Doro Headrest SystemHBL · Traditional 08/04/2000SE

Questions and answers

When was DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) cleared by the FDA?

DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) (K193438) received a 510(k) decision of Substantially Equivalent on June 2, 2020, 174 days after the submission was received.

What is the product code of K193438?

The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.