Cleared Special

Symmetry Sharp Kerrison Rongeur (K161744) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161744 · Symmetry Surgical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
75d
Days
Class 2
Risk

K161744 is an FDA 510(k) clearance for the Symmetry Sharp Kerrison Rongeur. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Symmetry Surgical, Inc. (Antioch, US). The FDA issued a Cleared decision on September 7, 2016 after a review of 75 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Symmetry Surgical, Inc. devices

Submission Details

510(k) Number K161744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2016
Decision Date September 07, 2016
Days to Decision 75 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 148d · This submission: 75d
Pathway characteristics
Modification to existing cleared device.

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 11
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K161744.
Wiggins Medical Surgical Instruments
K200383 · Wiggins Medical · Jul 2020
Ace Medical Surgical Instruments
K200387 · Ace Medical · Jul 2020
Steribite
K180949 · Rjr Surgical, Inc. · Nov 2018
BRAY RONGEUR
K954699 · Johnson & Johnson Professionals, Inc. · Dec 1995
AUTO SUTURE KERRISON SPINAL RONGEUR
K943116 · United States Surgical, A Division of Tyco Healthc · Jul 1994