Cleared Special

K020480 - RBM

K020480 is an FDA 510(k) clearance for RBM, manufactured by Smith & Nephew, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGS cleared through the Special 510(k) pathway after a 27-day FDA review.

K020480 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
27d
Days
Class 1
Risk

K020480 is an FDA 510(k) clearance for the RBM. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on March 12, 2002 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4930 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020480

510(k) Number K020480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

KGS Device Classification - Class 1, General Controls

Product Code KGS Retention Device, Suture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4930
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGS Retention Device, Suture

All 19
Devices cleared under the same product code (KGS) and FDA review panel - the closest regulatory comparables to K020480.
SOFT TISSUE ANCHORING WASHERS
K030031 · Accu-Speed, Incorporated · Jan 2003
SUTURE LOCK
K964935 · Smith & Nephew Endoscopy, Inc. · Feb 1997
ACUFEX ROTATOR CUFF FIXATION BUTTON
K941740 · Acufex Microsurgical, Inc. · Jun 1995
MITEK CONE WASHER
K930675 · Mitek Surgical Products, Inc. · Nov 1993
VENTROFIL TENSION RELIEF SUTURE SET
K904435 · Aesculap, Inc. · Aug 1991
TRAY DOUGH
K911225 · The Hygenic Corp. · Apr 1991
K020480 · RBM
Download PDF FDA Summary Smith & Nephew, Inc.