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)

Q: What is the product code of K241883?

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

FDA 510(k) K241883 · Pro Med Instruments GmbH

Substantially Equivalent

510(k) numberK241883

Submission

Device name: 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)
Applicant: Pro Med Instruments GmbH
Freiburg, DE
Received: June 28, 2024
Decision date: July 26, 2024
Decision: Substantially Equivalent (SESE)
Type: Special 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)	Device	Applicant	Decision
K250423	mb-FIX Cranial Stabilization SystemsHBL · Traditional	Medical Bees GmbH	11/06/2025SE
K240319	DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)HBL · Traditional	Pro Med Instruments GmbH	04/24/2024SE
K203505	DORO QR3 Headrest System (Aluminum)HBL · Traditional	Pro Med Instruments GmbH	03/29/2021SE
K193438	DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull…HBL · Traditional	Pro Med Instruments GmbH	06/02/2020SE
K191740	DORO LUCENT® iXI and iMRI Headrest SystemHBL · Traditional	Pro Med Instruments GmbH	02/21/2020SE
K191701	Arcus Head Fixation FrameHBL · Traditional	Mri Interventions, Inc.	11/15/2019SE
K191979	DORO QR3 XTom Headholder SystemHBL · Traditional	Pro Med Instruments GmbH	10/22/2019SE
K163322	TZ SKULL PIN AdultHBL · Traditional	Tz Medical, Inc.	02/23/2017SE
K142238	MAYFIELD Skull ClampHBL · Traditional	Integra LifeSciences Corporation	11/24/2014SE
K141950	HFD100 Rocker Arm AccessoryHBL · Special	Imris, Inc.	09/04/2014SE

More from Imris, Inc.

510(k)	Device	Decision
K240319	DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)HBL · Traditional	04/24/2024SE
K203505	DORO QR3 Headrest System (Aluminum)HBL · Traditional	03/29/2021SE
K193438	DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull…HBL · Traditional	06/02/2020SE
K191740	DORO LUCENT® iXI and iMRI Headrest SystemHBL · Traditional	02/21/2020SE
K191979	DORO QR3 XTom Headholder SystemHBL · Traditional	10/22/2019SE
K063494	Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsHBL · Traditional	05/21/2007SE
K070997	Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables…GEI · Traditional	05/16/2007SE
K032331	Doro Radiolucent Headrest System and Horseshoe Headrests,And Non-Radiolucent J-Arm…HBL · Traditional	11/20/2003SE
K001808	Doro Headrest SystemHBL · Traditional	08/04/2000SE

Questions and answers

When was 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) cleared by the FDA?

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) received a 510(k) decision of Substantially Equivalent on July 26, 2024, 28 days after the submission was received.

What is the product code of K241883?

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