Cleared Traditional

K102101 - SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA (FDA 510(k) Clearance)

Class I Neurology device.

K102101 · Surgivision, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
183d
Days
Class 1
Risk

K102101 is an FDA 510(k) clearance for the SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA. Classified as Cannula, Ventricular (product code HCD), Class I - General Controls.

Submitted by Surgivision, Inc. (Irvine, US). The FDA issued a Cleared decision on January 26, 2011 after a review of 183 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4060 - 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 Surgivision, Inc. devices

Submission Details

510(k) Number K102101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2010
Decision Date January 26, 2011
Days to Decision 183 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
35d slower than avg
Panel avg: 148d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HCD Cannula, Ventricular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4060
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.