Cleared Traditional

K914083 - ICAN K DISSECTOR SPONGES

K914083 is an FDA 510(k) clearance for ICAN K 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 28-day FDA review.

K914083 · Icn Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
28d
Days
Class 1
Risk

K914083 is an FDA 510(k) clearance for the ICAN K 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 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 878.4450 - 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 - K914083

510(k) Number K914083 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.

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 K914083.
SPECIALTY SPONGES
K920355 · Ultracell Medical Technologies, Inc. · Aug 1992
SURGICAL SPONGES
K920356 · Ultracell Medical Technologies, Inc. · Aug 1992
SUAN FLAT DISSECTOR SPONGES
K914082 · Icn Pharmaceuticals, Inc. · Nov 1991
ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
K903358 · Advance Medical Designs, Inc. · Nov 1990
QUALTEX NEUROLOK SURGICAL SPONGE
K884790 · Deroyal Industries, Inc. · Dec 1988
MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
K873391 · Ormed Mfg., Inc. · Sep 1987