Cleared Traditional

K123096 - REPROCESSED VESSEL SEALER

K123096 is the FDA 510(k) clearance for REPROCESSED VESSEL SEALER by Sterilmed, Inc.. It is a Class 2 General & Plastic Surgery device (product code NUJ) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K123096 · Sterilmed, Inc. · General & Plastic Surgery device
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Jan 2013
Decision
115d
Days
Class 2
Risk

K123096 is an FDA 510(k) clearance for the REPROCESSED VESSEL SEALER. Classified as Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (product code NUJ), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on January 25, 2013 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sterilmed, Inc. devices

Submission Details

510(k) Number K123096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2012
Decision Date January 25, 2013
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (NUJ) and FDA review panel - the closest regulatory comparables to K123096.
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 CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
K131614 · Covidien · Aug 2013
REPROCESSED SURGICAL ELECTRIC INSTRUMENT
K120040 · Sterilmed, Inc. · Oct 2012
RESPROCESSED SERFAS ENERGY PROBE
K121855 · Stryker Sustainability Solutions · Aug 2012
REPROCESSED SCISSOR TIPS
K073613 · Sterilmed, Inc. · Feb 2008