510(k) clearance

Fast Absorbing PGLA

FDA 510(k) source

510(k) number

K263073

Applicant

Riverpoint Medical, LLC

Decision date

Sep 29, 2026

Date received

Sep 1, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

GAM

Device type

Suture, Absorbable, Synthetic, Polyglycolic Acid

Device class

Class II

Regulation

21 CFR 878.4493

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Portland, OR, US