Cleared Traditional

K983163 - BIATAIN FOAM DRESSING

K983163 · Coloplast Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
97d
Days
-
Risk

K983163 is an FDA 510(k) clearance for the BIATAIN FOAM DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 97 days - within the typical 510(k) review window.

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: 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 Coloplast Corp. devices

FDA 510(k) Submission Details - K983163

510(k) Number K983163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1998
Decision Date December 16, 1998
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
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 457
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K983163.
MODIFICATION OF CUTINOVA FOAM DRESSING
K984599 · Beiersdorf-Jobt, Inc. · Mar 1999
SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD
K984208 · Argentum International, LLC · Feb 1999
COMPEED PSORIASIS DRESSING
K982493 · Coloplast Corp. · Jan 1999
BIATAIN FOAM ADHESIVE DRESSING
K983173 · Coloplast Corp. · Dec 1998
SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN
K983249 · Euromed, Inc. · Nov 1998
SILVERLON CONTACT WOUND DRESSING
K981299 · Argentum International, LLC · Sep 1998