Cleared Traditional

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)

K161086 · Sterilmed, Inc. · General & Plastic Surgery

Sep 2016

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K161086 is an FDA 510(k) clearance for the Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm), a Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (Class II — Special Controls, product code NUJ), submitted by Sterilmed, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 20, 2016, 155 days after receiving the submission on April 18, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K161086 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NUJ — Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class	Class II — 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).