Cleared Traditional

K891993 - COLLAGEN NEUROSPONGE

K891993 is an FDA 510(k) clearance for COLLAGEN NEUROSPONGE, manufactured by Vitaphore Corp.. The device is a Class 2 Neurology device with product code HBA cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K891993 · Vitaphore Corp. · Neurology device
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Mar 1990
Decision
360d
Days
Class 2
Risk

K891993 is an FDA 510(k) clearance for the COLLAGEN NEUROSPONGE. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by Vitaphore Corp. (Menlo Park, US). The FDA issued a Cleared decision on March 23, 1990 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4700 - 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. Elevated predicate reliance profile. 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 Vitaphore Corp. devices

FDA 510(k) Submission Details - K891993

510(k) Number K891993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1989
Decision Date March 23, 1990
Days to Decision 360 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 148d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBA Device Classification - Class 2, Special Controls

Product Code HBA Neurosurgical Paddie
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4700
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.