Cleared Traditional

K972634 - ULTRACELL SUCTION SPONGE

K972634 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 GDY cleared through the Traditional 510(k) pathway after a 156-day FDA review.

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

FDA 510(k) Submission Details - K972634

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 115d · This submission: 156d
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 57
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K972634.
CPR LAP SPONGES
K960236 · Custom Pack Reliability · Mar 1996
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
K955599 · Stryker Corp. · Feb 1996
ULTRACELL ORTHOPEDIC SPONGES
K950370 · Ultracell Medical Technologies, Inc. · Apr 1995
ULTRACELL ORTHOPEDIC SPONGES
K950372 · Ultracell Medical Technologies, Inc. · Apr 1995
ULTRACELL ORTHOPEDIC SPONGES
K950373 · Ultracell Medical Technologies, Inc. · Apr 1995
ULTRACELL RETRACTOR COVERS
K950659 · Ultracell Medical Technologies, Inc. · Apr 1995