Cleared Traditional

K920355 - SPECIALTY SPONGES

K920355 is an FDA 510(k) clearance for SPECIALTY SPONGES, 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 192-day FDA review.

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

FDA 510(k) Submission Details - K920355

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.

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 13
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K920355.
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
K955599 · Stryker Corp. · Feb 1996
STERILE LAPAROTOMY SPONGES
K934971 · Medsurg Industries, Inc. · Feb 1994
SUAN FLAT DISSECTOR SPONGES
K914082 · Icn Pharmaceuticals, Inc. · Nov 1991
ICAN K DISSECTOR SPONGES
K914083 · Icn Pharmaceuticals, Inc. · Oct 1991
ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
K903358 · Advance Medical Designs, Inc. · Nov 1990
QUALTEX NEUROLOK SURGICAL SPONGE
K884790 · Deroyal Industries, Inc. · Dec 1988