Camino Hand Drill - Model 030

FDA 510(k) K862160 · Camino Laboratories, Inc.

Substantially Equivalent

510(k) numberK862160

Submission

Device name
Camino Hand Drill - Model 030
Applicant
Camino Laboratories, Inc.
San Diego, CA, US
Received
June 6, 1986
Decision date
July 18, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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)DeviceApplicantDecision
K252696LegacyHBG · Traditional Phasor Health, LLC11/21/2025SE
K153587Taps for Resorbable ScrewsHBG · Traditional Synthes (USA) Products, LLC01/18/2017SE
K162884SpineGuard DSG Zavation Screw SystemHBG · Traditional Spineguard S.A.01/12/2017SE
K160129MRII Cranial Drill and AccessoriesHBG · Special Mri Interventions, Inc.03/26/2016SE
K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG · Special Mri Interventions, Inc.07/08/2015SE
K122456Mrii Crainial DrillHBG · Traditional Mri Interventions, Inc.03/22/2013SE
K022712Hand Drill, Model 11-9901-7HBG · Traditional Medical Design, LLC11/12/2002SE
K022370Framelock; Framelock AccessoriesHBG · Traditional Medtronic Xomed, Inc.10/18/2002SE
K961113CNS Interchangeable Bit Cranial DrillHBG · Traditional Clinical Neuro Systems, LLC06/05/1996SE
K932402Modification to Ghajar Guide Twist DrillHBG · Traditional Neurodynamics, Inc.08/05/1993SE

More from Neurodynamics, Inc.

510(k)DeviceDecision
K932769Camino Ventricular Drainage SystemJXG · Traditional 03/30/1995SE
K930222Camino Ventricular Access DeviceJXG · Traditional 04/15/1993SE
K930221Camino Ventricular Transducer AccessoryGWM · Traditional 04/15/1993SE
K920088Camino Ventricular NeedleHCD · Traditional 05/01/1992SE
K914735Ventricular Pressure Monitoring Kit, Model 110-4HMGWM · Traditional 01/17/1992SE
K912833Camino Model M420: Monit Inter W/Mean Pres DisplayDSK · Traditional 09/23/1991SE
K893232Model V420 Direct Pressure Monitor & 427 WaveformDSK · Traditional 07/14/1989SE
K881183Ventricular Bolt Pressure Monitoring Kit #110-4HGWM · Traditional 05/04/1988SE
K863969Camino Compartmental Press Monitor CATH/110-4DDXO · Traditional 05/27/1987SE
K861961Camino CSF Drainage System Model 040JXG · Traditional 08/12/1986SE

Questions and answers

When was Camino Hand Drill - Model 030 cleared by the FDA?

Camino Hand Drill - Model 030 (K862160) received a 510(k) decision of Substantially Equivalent on July 18, 1986, 42 days after the submission was received.

What is the product code of K862160?

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