Cleared Traditional

K892531 - NEUROSURGICAL DRILLS: STILLE, HUDSON

K892531 is an FDA 510(k) clearance for NEUROSURGICAL DRILLS: STILLE, manufactured by Zinnanti Surgical Instruments, Inc.. The device is a Class 2 Neurology device with product code HBG cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K892531 · Zinnanti Surgical Instruments, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1989
Decision
24d
Days
Class 2
Risk

K892531 is an FDA 510(k) clearance for the NEUROSURGICAL DRILLS: STILLE, HUDSON. Classified as Drills, Burrs, Trephines & Accessories (manual) (product code HBG), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 5, 1989 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4300 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zinnanti Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K892531

510(k) Number K892531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date May 05, 1989
Days to Decision 24 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 148d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBG Device Classification - Class 2, Special Controls

Product Code HBG Drills, Burrs, Trephines & Accessories (manual)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBG Drills, Burrs, Trephines & Accessories (manual)

All 11
Devices cleared under the same product code (HBG) and FDA review panel - the closest regulatory comparables to K892531.
CNS INTERCHANGEABLE BIT CRANIAL DRILL
K961113 · Clinical Neuro Systems, LLC · Jun 1996
PS MEDICAL VENTRICULOSTOMY KIT
K915546 · Pudenz-Schulte Medical Research Corp. · Dec 1991
PS MEDICAL CRANIAL HAND DRILL
K904283 · Pudenz-Schulte Medical Research Corp. · Oct 1990
CAMINO HAND DRILL - MODEL 030
K862160 · Camino Laboratories, Inc. · Jul 1986