Cleared Traditional

K110751 - CODMAN BACTISEAL ENDOSCOPIC VENTICULAR ...

K110751 is the FDA 510(k) clearance for CODMAN BACTISEAL ENDOSCOPIC VENTICULAR ... by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K110751 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
52d
Days
Class 2
Risk

K110751 is an FDA 510(k) clearance for the CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on May 9, 2011 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K110751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2011
Decision Date May 09, 2011
Days to Decision 52 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
96d faster than avg
Panel avg: 148d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - JXG Shunt, Central Nervous System And Components

All 117
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K110751.
AESCULAP- MEITHKE SHUNT SYSTEM
K110206 · Aesculap, Inc. · Oct 2011
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
K112156 · Medos International SARL · Oct 2011
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
K101381 · Integra LifeSciences Corporation · Jul 2011
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS
K102961 · Codman & Shurtleff, Inc. · Feb 2011
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
K102589 · Codman & Shurtleff, Inc. · Jan 2011
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
K103003 · Aesculap, Inc. · Nov 2010