Cleared Special

K203081 - RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture

K203081 is an FDA 510(k) clearance for RAM COR-SUTURE QUCIK LOAD Surgical Suture, manufactured by Lsi Solutions. The device is a Class 2 General & Plastic Surgery device with product code GAS cleared through the Special 510(k) pathway after a 42-day FDA review.

K203081 · Lsi Solutions · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
42d
Days
Class 2
Risk

K203081 is an FDA 510(k) clearance for the RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture. Classified as Suture, Nonabsorbable, Synthetic, Polyester (product code GAS), Class II - Special Controls.

Submitted by Lsi Solutions (Victor, US). The FDA issued a Cleared decision on November 24, 2020 after a review of 42 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.

FDA 510(k) Submission Details - K203081

510(k) Number K203081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2020
Decision Date November 24, 2020
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

GAS Device Classification - Class 2, Special Controls

Product Code GAS Suture, Nonabsorbable, Synthetic, Polyester
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 - GAS Suture, Nonabsorbable, Synthetic, Polyester

All 16
Devices cleared under the same product code (GAS) and FDA review panel - the closest regulatory comparables to K203081.
RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
K203120 · Lsi Solutions, Inc. · Nov 2020
ARTHREX BIOWIRE
K091018 · Arthrex, Inc. · Jul 2010
MR-III
K002261 · Smith & Nephew, Inc. · Oct 2000
SUTURE CORD
K953128 · Phoenix Biomedical Corp. · Feb 1996
BRAIDED POLYESTER SUTURE MATERIAL
K923161 · Mitek Surgical Products, Inc. · Dec 1992
PETERS CARDIOFLON(TM) SUTURE
K913101 · Promedica Products, Inc. · Aug 1992
K203081 · RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
Download PDF FDA Summary Lsi Solutions