Cleared Traditional

K231953 - Biatain Fiber Ag (33570 - 5 cm x 5 cm /...

Also marketed or referenced as:
Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in) Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in) Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in) Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)
K231953 · Coloplast Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
266d
Days
-
Risk

K231953 is an FDA 510(k) clearance for the Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on March 22, 2024 after a review of 266 days - an extended review 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: 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

Submission Details

510(k) Number K231953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2023
Decision Date March 22, 2024
Days to Decision 266 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
151d slower than avg
Panel avg: 115d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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