Cleared Traditional

K982804 - SPYROGEL HYDROGEL WOUND AND BURN DRESSING

K982804 · Innovative Technologies (Us), Inc. · General & Plastic Surgery device
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Dec 1998
Decision
128d
Days
-
Risk

K982804 is an FDA 510(k) clearance for the SPYROGEL HYDROGEL WOUND AND BURN DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Innovative Technologies (Us), Inc. (Golden,, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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

FDA 510(k) Submission Details - K982804

510(k) Number K982804 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 10, 1998
Decision Date December 16, 1998
Days to Decision 128 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 65
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K982804.
MODIFICATION OF BIONECT HYDROGEL FOAM
K984267 · Fidia Pharmaceutical Corp. · Feb 1999
BIONECT HYDROGEL
K984413 · Fidia Pharmaceutical Corp. · Feb 1999
BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET
K984082 · Emox 911 CC · Jan 1999
NU-GEL * WOUND DRESSING
K983362 · Johnson & Johnson Medical, Inc. · Dec 1998
SWEEN WOUN'DRES
K983042 · Coloplast Corp. · Nov 1998
BRENNEN MEDICAL BETA GLUCAN GEL
K982825 · Brennen Medical, Inc. · Nov 1998