Cleared Traditional

NEUROLOGICAL RONGEURS - VARIOUS TYPES (K892535) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K892535 · Zinnanti Surgical Instruments, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1989
Decision
30d
Days
Class 2
Risk

K892535 is an FDA 510(k) clearance for the NEUROLOGICAL RONGEURS - VARIOUS TYPES. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 11, 1989 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4840 - 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

Submission Details

510(k) Number K892535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date May 11, 1989
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAE Rongeur, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4840
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 - HAE Rongeur, Manual

All 35
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K892535.
Geister K-Rex rongeurs
K242759 · Geister Medizin Technik GmbH · Jun 2025
SQ.line KERRISON
K223596 · Aesculap, Inc. · Jun 2023
Rebellion, Phantom Multi-Bite Kerrison Rongeur
K230256 · Morpheus AG · Mar 2023
Rebellion
K221818 · Morpheus AG · Oct 2022
KLS Martin Neuro Rongeurs
K210741 · KLS-Martin L.P. · Jun 2022
Rebellion, Phantom Multi-Bite Kerrison Rongeur 
K200768 · Morpheus AG · May 2021