Cleared Traditional

K972635 - ULTRACELL SUCTION SPONGE

K972635 is an FDA 510(k) clearance for ULTRACELL SUCTION SPONGE, manufactured by Ultracell Medical Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K972635 · Ultracell Medical Technologies, Inc. · General & Plastic Surgery device
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Oct 1997
Decision
79d
Days
Class 1
Risk

K972635 is an FDA 510(k) clearance for the ULTRACELL SUCTION SPONGE. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Ultracell Medical Technologies, Inc. (North Stonington, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 Ultracell Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K972635

510(k) Number K972635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1997
Decision Date October 01, 1997
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBX Catheter, Irrigation

All 34
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K972635.
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
K973703 · Allegiance Healthcare Corp. · Dec 1997
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K961295 · Sil-Med Corp. · Jun 1996
CLOSED FLUID COLLECTION SYSTEM
K961147 · B.Braun Medical, Inc. · May 1996
JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
K960955 · Baxter Healthcare Corp · May 1996
HYDROLOGY 5000
K955339 · Northgate Technologies, Inc. · Mar 1996