Cleared Traditional

K063517 - HEALADEX-P

K063517 · Healagenics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
87d
Days
-
Risk

K063517 is an FDA 510(k) clearance for the HEALADEX-P. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Healagenics, Inc. (Woburn, US). The FDA issued a Cleared decision on February 16, 2007 after a review of 87 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K063517

510(k) Number K063517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2006
Decision Date February 16, 2007
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 708
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K063517.
SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
K984204 · Argentum International, LLC · Mar 2007
SILVERLON ADHESIVE STRIP
K984205 · Argentum International, LLC · Mar 2007
RETRO-TECH DRESSING
K060832 · Retro-Tech, LLC · Mar 2007
EXSEPT WC WOUND CLEANSER
K061467 · Alcavis International, Inc. · Feb 2007
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
K062559 · Laboratoires Urgo · Jan 2007
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
K061554 · Molnlycke Health Care · Jan 2007
K063517 · HEALADEX-P
Download PDF FDA Summary Healagenics, Inc.