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FDA 510(k)

BRAINLAB STEREOTACTIC ARC

K-Number: K992916 · 2000-01-11

ApplicantBrainlab
Decision Date2000-01-11
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAINLAB STEREOTACTIC ARC is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab. It received FDA 510(k) clearance on 2000-01-11 under 510(k) number K992916. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAINLAB STEREOTACTIC ARC?

BRAINLAB STEREOTACTIC ARC is a medical device that received FDA 510(k) clearance on 2000-01-11. The listed applicant is Brainlab. The 510(k) number is K992916.

When did BRAINLAB STEREOTACTIC ARC receive FDA 510(k) clearance?

BRAINLAB STEREOTACTIC ARC received FDA 510(k) clearance on 2000-01-11, under 510(k) number K992916.

Who is the listed applicant for BRAINLAB STEREOTACTIC ARC?

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

What is the FDA product code for BRAINLAB STEREOTACTIC ARC?

The FDA product code for BRAINLAB STEREOTACTIC ARC is HAW.

Related Clinical Trials

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Other records listing Brainlab 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.

K920880BRAINSCAN BRACHYTHERAPY MODULEK920879BRAINSCAN RADIOSURGERY MODULE

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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