Cleared Traditional

K983249 - SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN

K983249 · Euromed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
70d
Days
-
Risk

K983249 is an FDA 510(k) clearance for the SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Euromed, Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 70 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.

View all Euromed, Inc. devices

FDA 510(k) Submission Details - K983249

510(k) Number K983249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1998
Decision Date November 25, 1998
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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