Cleared Traditional

K073246 - ZENIEVA

K073246 is an FDA 510(k) clearance for ZENIEVA, manufactured by Gorbec Pharmaceutical Services, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAE cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K073246 · Gorbec Pharmaceutical Services, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
247d
Days
Class 1
Risk

K073246 is an FDA 510(k) clearance for the 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 July 23, 2008 after a review of 247 days - an extended review 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. 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 Gorbec Pharmaceutical Services, Inc. devices

FDA 510(k) Submission Details - K073246

510(k) Number K073246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2007
Decision Date July 23, 2008
Days to Decision 247 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
132d slower than avg
Panel avg: 115d · This submission: 247d
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 14
Devices cleared under the same product code (NAE) and FDA review panel - the closest regulatory comparables to K073246.
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
INTRASITE
K942748 · Smith & Nephew United, Inc. · Jun 1994