Cleared Special

K020480 - RBM
(FDA 510(k) Clearance)

K020480 · Smith & Nephew, Inc. · General & Plastic Surgery
Mar 2002
Decision
27d
Days
Class 1
Risk

K020480 is an FDA 510(k) clearance for the RBM. This device is classified as a Retention Device, Suture (Class I — General Controls, product code KGS).

Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on March 12, 2002, 27 days after receiving the submission on February 13, 2002.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4930.

Submission Details

510(k) Number K020480 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2002
Decision Date March 12, 2002
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KGS — Retention Device, Suture
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4930