Cleared Traditional

ULTRACELL SUCTION SPONGE (K972634) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K972634 · Ultracell Medical Technologies, Inc. · General & Plastic Surgery device
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Dec 1997
Decision
156d
Days
Class 1
Risk

K972634 is an FDA 510(k) clearance for the ULTRACELL SUCTION SPONGE. 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 December 17, 1997 after a review of 156 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 K972634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1997
Decision Date December 17, 1997
Days to Decision 156 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
41d slower than avg
Panel avg: 115d · This submission: 156d
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.