Cleared Traditional

SPECIALTY SPONGES (K920355) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K920355 · Ultracell Medical Technologies, Inc. · General & Plastic Surgery device
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Aug 1992
Decision
192d
Days
Class 1
Risk

K920355 is an FDA 510(k) clearance for the SPECIALTY SPONGES. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Ultracell Medical Technologies, Inc. (North Stonington, US). The FDA issued a Cleared decision on August 6, 1992 after a review of 192 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ultracell Medical Technologies, Inc. devices

Submission Details

510(k) Number K920355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1992
Decision Date August 06, 1992
Days to Decision 192 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 115d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.