GHAJAR GUIDE TWIST DRILL— 510(k) K875018

Substantially Equivalent

Neurodynamics, Inc.

FDA 510(k) clearance K875018 for GHAJAR GUIDE TWIST DRILL, Substantially Equivalent on 1988-01-28. Applicant: Neurodynamics, Inc.. Device class: 2.

Clearance details

Applicant: Neurodynamics, Inc.
Product code: Code HBG
Device class: Class 2
Regulation: 21 CFR 882.4300
Advisory panel: Neurology
Date received: 1987-12-04
Decision date: 1988-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HBG

K252696 — LEGACY2025-11-21
K153587 — Taps for Resorbable Screws2017-01-18
K162884 — SpineGuard DSG Zavation Screw System2017-01-12
K160129 — MRII Cranial Drill and Accessories2016-03-26
K151536 — SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm2015-07-08

More clearances from Neurodynamics, Inc.

K932402 — MODIFICATION TO GHAJAR GUIDE TWIST DRILL1993-08-05
K875205 — TRI-FLOW CATHETER1988-05-31
K875019 — GHAJAR GUIDE SYSTEM FOR THE PERFORATOR1988-01-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.