Cleared Traditional

K092227 - JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS

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

K092227 · Integra Lifesciences Corp. · Neurology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K092227

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
Combination Product No
PCCP Authorized No
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.

HAE Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K092227.
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
K130541 · Symmetry Surgical · Aug 2013
IO-TOME DEVICE
K113073 · Baxano, Inc. · Jul 2012
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K113533 · Baxano, Inc. · Apr 2012
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