Cleared Traditional

K161086 - Reprocessed Harmonic Shears with Adapti...

K161086 is the FDA 510(k) clearance for Reprocessed Harmonic Shears with Adapti... by Sterilmed, Inc.. It is a Class 2 General & Plastic Surgery device (product code NUJ) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K161086 · Sterilmed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
155d
Days
Class 2
Risk

K161086 is an FDA 510(k) clearance for the Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reproces.... Classified as Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (product code NUJ), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 20, 2016 after a review of 155 days - an extended review 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: 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 K161086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2016
Decision Date September 20, 2016
Days to Decision 155 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
40d slower than avg
Panel avg: 115d · This submission: 155d
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 20
Devices cleared under the same product code (NUJ) and FDA review panel - the closest regulatory comparables to K161086.
Reprocessed DePuy Mitek Ablation Wand
K173740 · Renovo, Inc. · Mar 2018
Reprocessed ArthoCare Ablation Wand
K173741 · Renovo, Inc. · Mar 2018
Reprocessed ArthroCare ENT Coblator
K172647 · Renovo, Inc. · Feb 2018
Reprocessed Vessel Sealer
K152134 · Sterilmed, Inc. · Jan 2016
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
K143260 · Sterilmed, Inc. · Feb 2015
REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
K131614 · Covidien · Aug 2013