Cleared Traditional

K991061 - DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING

K991061 is an FDA 510(k) clearance for DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING, manufactured by Dermaphylyx, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K991061 · Dermaphylyx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
90d
Days
Class 1
Risk

K991061 is an FDA 510(k) clearance for the DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING. Classified as Dressing, Wound, Hydrogel Without Drug And/or Biologic (product code NAE), Class I - General Controls.

Submitted by Dermaphylyx, Inc. (Woburn, US). The FDA issued a Cleared decision on June 28, 1999 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4022 - the FDA general and plastic surgery device framework. 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 Dermaphylyx, Inc. devices

FDA 510(k) Submission Details - K991061

510(k) Number K991061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1999
Decision Date June 28, 1999
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

NAE Device Classification - Class 1, General Controls

Product Code NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4022
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic

All 15
Devices cleared under the same product code (NAE) and FDA review panel - the closest regulatory comparables to K991061.
GILTECH PLUS HYDROGEL SKIN DRESSING
K992094 · Giltech Plus, Inc. · Sep 1999
AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
K972646 · Ludlow Technical Products · Aug 1997
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
K971597 · Coloplast Corp. · Jul 1997
HYDROGEL SKIN DRESSING
K962352 · North American Sterilization & Packaging Co. · Aug 1996
AQUAFLO HYDROGEL WOUND DRESSING & PACKER
K952945 · Sherwood Medical Co. · Aug 1995
CURAGEL HYDROGEL WOUND DRESSING
K950412 · Kendall Healthcare Products Co. Div.Of Tyco Health · Mar 1995