Cleared Special

K040232 - LSI SEW-RIGHT R SERIES SUTURE PLACEMENT...

K040232 is the FDA 510(k) clearance for LSI SEW-RIGHT R SERIES SUTURE PLACEMENT... by Lsi Solutions. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Special 510(k) pathway after a 28-day FDA review.

K040232 · Lsi Solutions · General & Plastic Surgery device
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Mar 2004
Decision
28d
Days
Class 2
Risk

K040232 is an FDA 510(k) clearance for the LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT S.... Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Lsi Solutions (Victor, US). The FDA issued a Cleared decision on March 1, 2004 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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.

View all Lsi Solutions devices

Submission Details

510(k) Number K040232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2004
Decision Date March 01, 2004
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 95
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K040232.
SMITH & NEPHEW ULTRABRAID SUTURE
K041216 · Smith & Nephew, Inc. · Jun 2004
DURABRAID SUTURE
K040789 · Smith & Nephew, Inc. · Jun 2004
FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE
K040472 · Teleflex Medical · Mar 2004
FORCE FIBER
K033654 · Teleflex Medical · Jan 2004
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239
K032245 · Arthrex, Inc. · Jan 2004
STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
K032901 · Stryker Endoscopy · Dec 2003