Cleared Special

HS Fiber

K252201 · Riverpoint Medical · General & Plastic Surgery
Aug 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K252201 is an FDA 510(k) clearance for the HS Fiber, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on August 13, 2025, 30 days after receiving the submission on July 14, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K252201 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2025
Decision Date August 13, 2025
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5000

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