Cleared Traditional

K894984 - MASCOT LAB SPONGE

K894984 is an FDA 510(k) clearance for MASCOT LAB SPONGE, manufactured by Mascot, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K894984 · Mascot, Inc. · General & Plastic Surgery device
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Sep 1989
Decision
28d
Days
Class 1
Risk

K894984 is an FDA 510(k) clearance for the MASCOT LAB SPONGE. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Mascot, Inc. (Cerritos, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4450 - the FDA general and plastic surgery 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 Mascot, Inc. devices

FDA 510(k) Submission Details - K894984

510(k) Number K894984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date September 05, 1989
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

GDY Device Classification - Class 1, General Controls

Product Code GDY Gauze/sponge, Internal, X-ray Detectable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4450
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.

Regulatory Peers - GDY Gauze/sponge, Internal, X-ray Detectable

All 58
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K894984.
SUAN FLAT DISSECTOR SPONGES
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K884790 · Deroyal Industries, Inc. · Dec 1988
MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
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