Cleared Traditional

SPYROSORB FOAM ISLAND WOUND DRESSING (K980673) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K980673 · Innovative Technologies (Us), Inc. · General & Plastic Surgery device
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May 1998
Decision
90d
Days
Class 1
Risk

K980673 is an FDA 510(k) clearance for the SPYROSORB FOAM ISLAND WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Innovative Technologies (Us), Inc. (Golden,, US). The FDA issued a Cleared decision on May 21, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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 Innovative Technologies (Us), Inc. devices

Submission Details

510(k) Number K980673 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 20, 1998
Decision Date May 21, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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 - KMF Bandage, Liquid

All 15
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K980673.
ALGISITE M
K983210 · Smith & Nephew, Inc. · Dec 1998
3M TEGASORB THIN HYDROCOLLOID DRESSING
K982892 · 3M Company · Oct 1998
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · 3M Company · Oct 1998
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc. · Nov 1997
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · 3M Company · May 1994
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982