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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 the device name listed in this FDA 510(k) record. The listed applicant is Rjr Surgical, Inc.. It received FDA 510(k) clearance on 2018-11-08 under 510(k) 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. The listed applicant is Rjr Surgical, Inc.. The 510(k) number is K180949.

When did Steribite receive FDA 510(k) clearance?

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

Who is the listed applicant for Steribite?

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

What is the FDA product code for Steribite?

The FDA product code for Steribite is HAE.

Related Devices (Code: HAE)

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.

K242759Geister K-Rex rongeursGeister Medizin Technik GmbHK223596SQ.line KERRISONAesculap, Inc.K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AGK221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AGK210741KLS Martin Neuro RongeursKLS-Martin L.P.K200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG

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.

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