Cleared Traditional

K092227 - JARIT

K092227 is the FDA 510(k) clearance for JARIT by Integra Lifesciences Corp.. It is a Class 2 Neurology device (product code HAE) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K092227 · Integra Lifesciences Corp. · Neurology device
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Optimized for regulatory review, auditing and printing
Feb 2010
Decision
209d
Days
Class 2
Risk

K092227 is an FDA 510(k) clearance for the JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (York, US). The FDA issued a Cleared decision on February 17, 2010 after a review of 209 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Integra Lifesciences Corp. devices

Submission Details

510(k) Number K092227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2009
Decision Date February 17, 2010
Days to Decision 209 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 148d · This submission: 209d
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 12
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K092227.
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
NEUROLOGICAL RONGEURS - VARIOUS TYPES
K892535 · Zinnanti Surgical Instruments, Inc. · May 1989