Cleared Traditional

K113693 - NIXALL TM WOUND AND SKIN CARE

K113693 · Seriously Clean, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K113693

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 115d · This submission: 361d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K113693.
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
K120181 · Huizhou Foryou Medical Devices Co., Ltd. · Feb 2013
VASHE WOUND THERAPY SOLUTION
K123072 · Puricore, Inc. · Feb 2013
VASHE SKIN AND WOUND HYDROGEL
K123071 · Puricore, Inc. · Jan 2013
L.A.M. IMP WOUND GEL
K123113 · Glycobiosciences, Inc. · Dec 2012
CURALINE POLYURETHANE FOAM AWC DRESSING
K121361 · Curaline, Inc. · Nov 2012
HYLATOPICPLUS LOTION
K121559 · Precision Dermatology Incorporated · Nov 2012
K113693 · NIXALL TM WOUND AND SKIN CARE
Download PDF FDA Summary Seriously Clean, Ltd.