Cleared Traditional

K881659 - TISSUE SECTION ADHESIVE

K881659 is an FDA 510(k) clearance for TISSUE SECTION ADHESIVE, manufactured by Surgipath Medical Industries, Inc.. The device is a Class 1 Pathology device with product code IFZ cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K881659 · Surgipath Medical Industries, Inc. · Pathology device
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Apr 1988
Decision
6d
Days
Class 1
Risk

K881659 is an FDA 510(k) clearance for the TISSUE SECTION ADHESIVE. Classified as Gelatin For Specimen Adhesion (product code IFZ), Class I - General Controls.

Submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - the FDA pathology 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 Surgipath Medical Industries, Inc. devices

FDA 510(k) Submission Details - K881659

510(k) Number K881659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1988
Decision Date April 21, 1988
Days to Decision 6 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 77d · This submission: 6d
Pathway characteristics
Predicate-based equivalence.

IFZ Device Classification - Class 1, General Controls

Product Code IFZ Gelatin For Specimen Adhesion
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
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.