Cleared Traditional

K062711 - ULTRA LOW PROFILE RONGEUR

K062711 is an FDA 510(k) clearance for ULTRA LOW PROFILE RONGEUR, manufactured by Baxano, Inc.. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K062711 · Baxano, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
177d
Days
Class 2
Risk

K062711 is an FDA 510(k) clearance for the ULTRA LOW PROFILE RONGEUR. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Baxano, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on March 7, 2007 after a review of 177 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.

FDA 510(k) Submission Details - K062711

510(k) Number K062711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2006
Decision Date March 07, 2007
Days to Decision 177 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
28d slower than avg
Panel avg: 149d · This submission: 177d
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 31
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K062711.
INSTRUMED RONGEUR
K081651 · Instrumed International, Inc. · Aug 2008
BAXANO ULTRA LOW PROFILE RONGEUR
K080494 · Baxano, Inc. · Mar 2008
MICROBLADE SHAVER AND ACCESSORIES
K063231 · Baxano, Inc. · Apr 2007
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
K023868 · Dannoritzer Medical Instruments · Feb 2003
BRAY RONGEUR
K954699 · Johnson & Johnson Professionals, Inc. · Dec 1995
KERRISON RONGEURS
K943583 · Enterprise Medical Corp. · Feb 1995