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FDA 510(k)

KOLIBRI IGS SYSTEMS

K-Number: K014256 · 2002-07-19

ApplicantBrainlab AG
Decision Date2002-07-19
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KOLIBRI IGS SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2002-07-19 under 510(k) number K014256. 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 KOLIBRI IGS SYSTEMS?

KOLIBRI IGS SYSTEMS is a medical device that received FDA 510(k) clearance on 2002-07-19. The listed applicant is Brainlab AG. The 510(k) number is K014256.

When did KOLIBRI IGS SYSTEMS receive FDA 510(k) clearance?

KOLIBRI IGS SYSTEMS received FDA 510(k) clearance on 2002-07-19, under 510(k) number K014256.

Who is the listed applicant for KOLIBRI IGS SYSTEMS?

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

What is the FDA product code for KOLIBRI IGS SYSTEMS?

The FDA product code for KOLIBRI IGS SYSTEMS is HAW.

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Other records listing Brainlab AG 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.

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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.

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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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