Cleared Traditional

K914086 - ICAN CYLINDRICAL SPONGES

K914086 is an FDA 510(k) clearance for ICAN CYLINDRICAL SPONGES, manufactured by Icn Pharmaceuticals, Inc.. The device is a Class 1 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K914086

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

GDX Device Classification - Class 1, General Controls

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

All 12
Devices cleared under the same product code (GDX) and FDA review panel - the closest regulatory comparables to K914086.
CCI CORNEAL SCARIFIER
K904505 · Buckman Co., Inc. · Apr 1991
1-CUT ACL GRAFT KNIFE
K905380 · Depuy, Inc. · Dec 1990
VESSEL LOOPS
K895682 · Applied Medical Technologies · Oct 1989
7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1
K851751 · Artiberia · Jun 1985
H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48
K834541 · Imm Enterprises , Ltd. · Jan 1984
PILLING DIAMOND KNIFE
K822749 · Narco Scientific · Oct 1982