Cleared Traditional

K971597 - COMFEEL PURILON GEL

K971597 is the FDA 510(k) clearance for COMFEEL PURILON GEL by Coloplast Corp.. It is a Class 1 General & Plastic Surgery device (product code NAE) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K971597 · Coloplast Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 1997
Decision
89d
Days
Class 1
Risk

K971597 is an FDA 510(k) clearance for the COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903). Classified as Dressing, Wound, Hydrogel Without Drug And/or Biologic (product code NAE), Class I - General Controls.

Submitted by Coloplast Corp. (Fort Worth, US). The FDA issued a Cleared decision on July 29, 1997 after a review of 89 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. 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.

View all Coloplast Corp. devices

Submission Details

510(k) Number K971597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1997
Decision Date July 29, 1997
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 7
Devices cleared under the same product code (NAE) and FDA review panel - the closest regulatory comparables to K971597.
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
NU-GEL ISLAND WOUND DRESSING
K932336 · Johnson & Johnson Medical, Inc. · Feb 1994
DUODERM HYDROCOLLOID GEL
K931618 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH
K915357 · Medtronic Vascular · May 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
K915359 · Medtronic Vascular · May 1992