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

FDA 510(k)

Steribite

K-Number: K180949 · 2018-11-08

ApplicantRjr Surgical, Inc.
Decision Date2018-11-08
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Steribite is a medical device manufactured by Rjr Surgical, Inc.. It received FDA 510(k) clearance on 2018-11-08 under approval number K180949. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steribite?

Steribite is a medical device that received FDA 510(k) clearance on 2018-11-08. It is manufactured by Rjr Surgical, Inc.. The 510(k) number is K180949.

When was Steribite approved by the FDA?

Steribite received FDA 510(k) clearance on 2018-11-08, under approval number K180949.

What company makes Steribite?

Steribite is manufactured by Rjr Surgical, Inc..

What is the FDA product code for Steribite?

The FDA product code for Steribite is HAE.

Related Devices (Code: HAE)

K161744Symmetry Sharp Kerrison RongeurSymmetry Surgical, Inc. K153243Fehling-PunchesFehling Instruments GmbH & Co. KG K152734Kerrison RongeursVitalitec Medizintechnik GmbH K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursK2 Medical GmbH & Co. KG K200383Wiggins Medical Surgical InstrumentsWiggins Medical K200387Ace Medical Surgical InstrumentsAce Medical

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.

↑