Cleared Traditional

K890021 - STERILE POLYHESIVE PBS DRESSING (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K890021 · Valleylab, Inc. · Neurology device
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Jun 1989
Decision
148d
Days
Class 3
Risk

K890021 is an FDA 510(k) clearance for the STERILE POLYHESIVE PBS DRESSING. Classified as Adhesive, Tissue For Aneurysmorrhaphy (product code KGF), Class III - Premarket Approval.

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on June 1, 1989 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity 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 Valleylab, Inc. devices

Submission Details

510(k) Number K890021 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 04, 1989
Decision Date June 01, 1989
Days to Decision 148 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 148d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGF Adhesive, Tissue For Aneurysmorrhaphy
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.