FDA 510(k)

Reprocessed Shavers/Burs

K-Number: K172092 · 2017-10-04

Decision Date2017-10-04

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Reprocessed Shavers/Burs is a medical device manufactured by Renovo, Inc.. It received FDA 510(k) clearance on 2017-10-04 under approval number K172092. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Shavers/Burs?

Reprocessed Shavers/Burs is a medical device that received FDA 510(k) clearance on 2017-10-04. It is manufactured by Renovo, Inc.. The 510(k) number is K172092.

When was Reprocessed Shavers/Burs approved by the FDA?

Reprocessed Shavers/Burs received FDA 510(k) clearance on 2017-10-04, under approval number K172092.

What company makes Reprocessed Shavers/Burs?

Reprocessed Shavers/Burs is manufactured by Renovo, Inc..

What is the FDA product code for Reprocessed Shavers/Burs?

The FDA product code for Reprocessed Shavers/Burs is HRX.

Other Devices by Renovo, Inc.

K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves K172093Reprocessed Covidien Trocar K173740Reprocessed DePuy Mitek Ablation Wand K173741Reprocessed ArthoCare Ablation Wand K172647Reprocessed ArthroCare ENT Coblator

Related Devices (Code: HRX)

K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation K161878PORTAGE SystemBaylis Medical Company, Inc. K162475mi-eye 2, mi-eye 2 monitorTrice Medical K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaProsurg, Inc. K160249ULTRA TelescopesOlympus Winter & Ibe GmbH K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.