Cleared Traditional

K131614 - REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM

K131614 is an FDA 510(k) clearance for REPROCESSED CLOSUREFAST RADIOFREQUENCY ..., manufactured by Covidien. The device is a Class 2 General & Plastic Surgery device with product code NUJ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K131614 · Covidien · General & Plastic Surgery device
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Aug 2013
Decision
87d
Days
Class 2
Risk

K131614 is an FDA 510(k) clearance for the REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST.... Classified as Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (product code NUJ), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on August 29, 2013 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Covidien devices

FDA 510(k) Submission Details - K131614

510(k) Number K131614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2013
Decision Date August 29, 2013
Days to Decision 87 days
Submission Type Traditional
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
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUJ Device Classification - Class 2, Special Controls

Product Code NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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 - NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

All 29
Devices cleared under the same product code (NUJ) and FDA review panel - the closest regulatory comparables to K131614.
Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider
K150538 · Stryker Sustainability Solutions · Jun 2015
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
K143260 · Sterilmed, Inc. · Feb 2015
REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
K133578 · Stryker Sustainability Solutions · Apr 2014
REPROCESSED VESSEL SEALER
K123096 · Sterilmed, Inc. · Jan 2013
REPROCESSED SURGICAL ELECTRIC INSTRUMENT
K120040 · Sterilmed, Inc. · Oct 2012
RESPROCESSED SERFAS ENERGY PROBE
K121855 · Stryker Sustainability Solutions · Aug 2012