Hand Drill, Model 11-9901-7

Q: What is the product code of K022712?

The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.

FDA 510(k) K022712 · Medical Design, LLC

Substantially Equivalent

510(k) numberK022712

Submission

Device name: Hand Drill, Model 11-9901-7
Applicant: Medical Design, LLC
Brandon, SD, US
Received: August 14, 2002
Decision date: November 12, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HBG – Drills, Burrs, Trephines & Accessories (Manual)
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4300
Specialty: Neurology

Other 510(k)s with product code HBG

510(k)	Device	Applicant	Decision
K252696	LegacyHBG · Traditional	Phasor Health, LLC	11/21/2025SE
K153587	Taps for Resorbable ScrewsHBG · Traditional	Synthes (USA) Products, LLC	01/18/2017SE
K162884	SpineGuard DSG Zavation Screw SystemHBG · Traditional	Spineguard S.A.	01/12/2017SE
K160129	MRII Cranial Drill and AccessoriesHBG · Special	Mri Interventions, Inc.	03/26/2016SE
K151536	SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG · Special	Mri Interventions, Inc.	07/08/2015SE
K122456	Mrii Crainial DrillHBG · Traditional	Mri Interventions, Inc.	03/22/2013SE
K022370	Framelock; Framelock AccessoriesHBG · Traditional	Medtronic Xomed, Inc.	10/18/2002SE
K961113	CNS Interchangeable Bit Cranial DrillHBG · Traditional	Clinical Neuro Systems, LLC	06/05/1996SE
K932402	Modification to Ghajar Guide Twist DrillHBG · Traditional	Neurodynamics, Inc.	08/05/1993SE
K915546	PS Medical Ventriculostomy KitHBG · Traditional	Pudenz-Schulte Medical Research Corp.	12/30/1991SE

More from Pudenz-Schulte Medical Research Corp.

510(k)	Device	Decision
K122497	Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate…KWQ · Traditional	10/15/2012SE
K121148	Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…HWC · Traditional	08/20/2012SE

Questions and answers

When was Hand Drill, Model 11-9901-7 cleared by the FDA?

Hand Drill, Model 11-9901-7 (K022712) received a 510(k) decision of Substantially Equivalent on November 12, 2002, 90 days after the submission was received.

What is the product code of K022712?

The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.