Cleared Traditional

Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); 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

Mar 2024

Decision

266d

Days

—

Risk

About This 510(k) Submission

K231953 is an FDA 510(k) clearance for the Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); 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), a Dressing, Wound, Drug, submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on March 22, 2024, 266 days after receiving the submission on June 30, 2023. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K231953 FDA.gov
FDA Decision	Cleared 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