Cleared Traditional

NIXALL TM WOUND AND SKIN CARE (K113693) - FDA 510(k) Clearance

K113693 · Seriously Clean, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
361d
Days
-
Risk

K113693 is an FDA 510(k) clearance for the NIXALL TM WOUND AND SKIN CARE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Seriously Clean, Ltd. (Nixa, US). The FDA issued a Cleared decision on December 11, 2012 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Seriously Clean, Ltd. devices

Submission Details

510(k) Number K113693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2011
Decision Date December 11, 2012
Days to Decision 361 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 115d · This submission: 361d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K113693.
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623 · B.Braun Medical, Inc. · Nov 2016
PRONTOSAN WOUND GEL X
K130857 · B.Braun Medical, Inc. · Oct 2013
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
K123679 · 3M Company · Feb 2013
CURAD ANTIBACTERIAL BANDAGE
K113583 · Medline Industries, Inc. · Apr 2012
3M TEGADERM MATRIX DRESSING
K110457 · 3M Company · Dec 2011
DURAFIBER AG
K103793 · Smith & Nephew, Inc. · May 2011