Cleared Traditional

K983042 - SWEEN WOUN'DRES

K983042 · Coloplast Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
86d
Days
-
Risk

K983042 is an FDA 510(k) clearance for the SWEEN WOUN'DRES. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Coloplast Corp. (North Mankato, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 86 days - a notably fast clearance cycle.

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: 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 Coloplast Corp. devices

FDA 510(k) Submission Details - K983042

510(k) Number K983042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1998
Decision Date November 25, 1998
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
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 89
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K983042.
BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET
K984082 · Emox 911 CC · Jan 1999
SPYROGEL HYDROGEL WOUND AND BURN DRESSING
K982804 · Innovative Technologies (Us), Inc. · Dec 1998
NU-GEL * WOUND DRESSING
K983362 · Johnson & Johnson Medical, Inc. · Dec 1998
BRENNEN MEDICAL BETA GLUCAN GEL
K982825 · Brennen Medical, Inc. · Nov 1998
NEUFINISH RESURFACING CREAM
K982577 · Neutrogena Corp. · Oct 1998
BIONECT HYDROGEL GAUZE PADS
K973721 · Fidia Pharmaceutical Corp. · Sep 1998