Cleared Traditional

K914086 - ICAN CYLINDRICAL SPONGES

K914086 is the FDA 510(k) clearance for ICAN CYLINDRICAL SPONGES by Icn Pharmaceuticals, Inc.. It is a Class 1 General & Plastic Surgery device (product code GDX) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K914086 · Icn Pharmaceuticals, Inc. · General & Plastic Surgery device
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Oct 1991
Decision
28d
Days
Class 1
Risk

K914086 is an FDA 510(k) clearance for the ICAN CYLINDRICAL SPONGES. Classified as Scalpel, One-piece (product code GDX), Class I - General Controls.

Submitted by Icn Pharmaceuticals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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

Submission Details

510(k) Number K914086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1991
Decision Date October 09, 1991
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDX Scalpel, One-piece
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GDX Scalpel, One-piece

Devices cleared under the same product code (GDX) and FDA review panel - the closest regulatory comparables to K914086.
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