Cleared Special

K082865 - MODIFICATION TO ZENIEVA

K082865 is an FDA 510(k) clearance for MODIFICATION TO ZENIEVA, manufactured by Gorbec Pharmaceutical Services, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAE cleared through the Special 510(k) pathway after a 24-day FDA review.

K082865 · Gorbec Pharmaceutical Services, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
24d
Days
Class 1
Risk

K082865 is an FDA 510(k) clearance for the MODIFICATION TO ZENIEVA. Classified as Dressing, Wound, Hydrogel Without Drug And/or Biologic (product code NAE), Class I - General Controls.

Submitted by Gorbec Pharmaceutical Services, Inc. (Durham, US). The FDA issued a Cleared decision on October 23, 2008 after a review of 24 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082865

510(k) Number K082865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date October 23, 2008
Days to Decision 24 days
Submission Type Special
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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 27
Devices cleared under the same product code (NAE) and FDA review panel - the closest regulatory comparables to K082865.
MODIFICATION TO ZENIEVA
K083721 · River'S Edge Pharmaceuticals, LLC · Jan 2009
ZENIEVA
K073246 · Gorbec Pharmaceutical Services, Inc. · Jul 2008
GILTECH PLUS HYDROGEL SKIN DRESSING
K992094 · Giltech Plus, Inc. · Sep 1999
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
K991061 · Dermaphylyx, Inc. · Jun 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
K082865 · MODIFICATION TO ZENIEVA
Download PDF FDA Summary Gorbec Pharmaceutical…