Cleared Traditional

K974251 - X-CELL WOUND DRESSING

K974251 · Xylos Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
221d
Days
-
Risk

K974251 is an FDA 510(k) clearance for the X-CELL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Xylos Corporation (East Burnswick, US). The FDA issued a Cleared decision on June 22, 1998 after a review of 221 days - an extended review 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: 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 Xylos Corporation devices

FDA 510(k) Submission Details - K974251

510(k) Number K974251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1997
Decision Date June 22, 1998
Days to Decision 221 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
106d slower than avg
Panel avg: 115d · This submission: 221d
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 98
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K974251.
POLYTUBE
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DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL
K980861 · Dumex Medical Surgical Products, Ltd. · May 1998
FLEXIGEL-G HYDROGEL WOUND DRESSING
K980097 · Innovative Technologies , Ltd. · Mar 1998