Cleared Traditional

K171879 - HylaGuard Moisturizing Cream

K171879 · Founders Science Group, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
115d
Days
-
Risk

K171879 is an FDA 510(k) clearance for the HylaGuard Moisturizing Cream. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Founders Science Group, LLC (Taunton, US). The FDA issued a Cleared decision on October 16, 2017 after a review of 115 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.

FDA 510(k) Submission Details - K171879

510(k) Number K171879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2017
Decision Date October 16, 2017
Days to Decision 115 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 115d · This submission: 115d
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 120
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K171879.
HYLATOPIC EMOLLIENT FOAM
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IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
K041342 · Stiefel Laboratories, Inc. · Jul 2005
SILVERSITE OR CALGITROL
K041268 · Adri · Sep 2004
SILVERSEAL
K040019 · Noble Fiber Technologies · Jul 2004
TENDERWET ACTIVE
K040517 · Medline Industries, Inc. · Mar 2004
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
K022587 · Medtrade Products , Ltd. · Aug 2003