FDA 510(k)

evoDrill Cranial Perforator

K-Number: K231403 · 2024-03-06

Decision Date2024-03-06

Product CodeHBF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

evoDrill Cranial Perforator is the device name listed in this FDA 510(k) record. The listed applicant is Evonos GmbH & Co. KG. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K231403. The device is classified under product code HBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the evoDrill Cranial Perforator?

evoDrill Cranial Perforator is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Evonos GmbH & Co. KG. The 510(k) number is K231403.

When did evoDrill Cranial Perforator receive FDA 510(k) clearance?

evoDrill Cranial Perforator received FDA 510(k) clearance on 2024-03-06, under 510(k) number K231403.

Who is the listed applicant for evoDrill Cranial Perforator?

The FDA 510(k) record lists Evonos GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for evoDrill Cranial Perforator?

The FDA product code for evoDrill Cranial Perforator is HBF.

Related Devices (Code: HBF)

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.

K213228NeuroLine Disposable Cranial Perforator with Hudson endEmd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.K183581Codman Disposable PerforatorsIntegra Lifesciences Corp.

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.