FDA 510(k)

Kerrison Rongeurs

K-Number: K152734 · 2016-06-18

Decision Date2016-06-18

Product CodeHAE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Kerrison Rongeurs is the device name listed in this FDA 510(k) record. The listed applicant is Vitalitec Medizintechnik GmbH. It received FDA 510(k) clearance on 2016-06-18 under 510(k) number K152734. 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 Kerrison Rongeurs?

Kerrison Rongeurs is a medical device that received FDA 510(k) clearance on 2016-06-18. The listed applicant is Vitalitec Medizintechnik GmbH. The 510(k) number is K152734.

When did Kerrison Rongeurs receive FDA 510(k) clearance?

Kerrison Rongeurs received FDA 510(k) clearance on 2016-06-18, under 510(k) number K152734.

Who is the listed applicant for Kerrison Rongeurs?

The FDA 510(k) record lists Vitalitec Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kerrison Rongeurs?

The FDA product code for Kerrison Rongeurs 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 GmbH K223596SQ.line KERRISONAesculap, Inc.K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG K221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AG K210741KLS Martin Neuro RongeursKLS-Martin L.P.K200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG

Official Source

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