Cleared Traditional

K020041 - IALUSET HYDROCOLLOID

K020041 · Institut Biochimique SA (Ibsa) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
66d
Days
-
Risk

K020041 is an FDA 510(k) clearance for the IALUSET HYDROCOLLOID. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Institut Biochimique SA (Ibsa) (Huntington Beach, US). The FDA issued a Cleared decision on March 14, 2002 after a review of 66 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 Institut Biochimique SA (Ibsa) devices

FDA 510(k) Submission Details - K020041

510(k) Number K020041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2002
Decision Date March 14, 2002
Days to Decision 66 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
49d faster than avg
Panel avg: 115d · This submission: 66d
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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