Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Reprocessed Shavers/Burs

K-Number: K172092 · 2017-10-04

ApplicantRenovo, Inc.
Decision Date2017-10-04
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Reprocessed Shavers/Burs is the device name listed in this FDA 510(k) record. The listed applicant is Renovo, Inc.. It received FDA 510(k) clearance on 2017-10-04 under 510(k) 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. The listed applicant is Renovo, Inc.. The 510(k) number is K172092.

When did Reprocessed Shavers/Burs receive FDA 510(k) clearance?

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

Who is the listed applicant for Reprocessed Shavers/Burs?

The FDA 510(k) record lists Renovo, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Renovo, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173740Reprocessed DePuy Mitek Ablation WandK173741Reprocessed ArthoCare Ablation WandK172647Reprocessed ArthroCare ENT CoblatorK172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesK172093Reprocessed Covidien Trocar

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)K250795PUREVUE™ FMSW.O.M. World of Medicine GmbHK252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC

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.

↑