Cleared Traditional

K914082 - SUAN FLAT DISSECTOR SPONGES

K914082 is an FDA 510(k) clearance for SUAN FLAT DISSECTOR SPONGES, manufactured by Icn Pharmaceuticals, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K914082 · Icn Pharmaceuticals, Inc. · General & Plastic Surgery device
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Nov 1991
Decision
77d
Days
Class 1
Risk

K914082 is an FDA 510(k) clearance for the SUAN FLAT DISSECTOR SPONGES. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Icn Pharmaceuticals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 77 days - a notably fast clearance 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: 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 Icn Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K914082

510(k) Number K914082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1991
Decision Date November 27, 1991
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 K914082.
X-RAY PACKING SPONGE
K935910 · Mcneil Healthcare, Inc. · Jan 1994
SPECIALTY SPONGES
K920355 · Ultracell Medical Technologies, Inc. · Aug 1992
SURGICAL SPONGES
K920356 · Ultracell Medical Technologies, Inc. · Aug 1992
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