Cleared Traditional

Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

K171324 · Surgical Instrument Service and Savings, Inc. · General & Plastic Surgery

Jun 2017

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K171324 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics, a Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (Class II — Special Controls, product code NUJ), submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on June 23, 2017, 49 days after receiving the submission on May 5, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K171324 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 2017
Decision Date	June 23, 2017
Days to Decision	49 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).