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FDA 510(k)

CBYON SURGICAL OPERATING SYSTEM (SOS)

K-Number: K000171 · 2000-03-13

ApplicantCbyon, Inc.
Decision Date2000-03-13
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CBYON SURGICAL OPERATING SYSTEM (SOS) is the device name listed in this FDA 510(k) record. The listed applicant is Cbyon, Inc.. It received FDA 510(k) clearance on 2000-03-13 under 510(k) number K000171. 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 CBYON SURGICAL OPERATING SYSTEM (SOS)?

CBYON SURGICAL OPERATING SYSTEM (SOS) is a medical device that received FDA 510(k) clearance on 2000-03-13. The listed applicant is Cbyon, Inc.. The 510(k) number is K000171.

When did CBYON SURGICAL OPERATING SYSTEM (SOS) receive FDA 510(k) clearance?

CBYON SURGICAL OPERATING SYSTEM (SOS) received FDA 510(k) clearance on 2000-03-13, under 510(k) number K000171.

Who is the listed applicant for CBYON SURGICAL OPERATING SYSTEM (SOS)?

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

What is the FDA product code for CBYON SURGICAL OPERATING SYSTEM (SOS)?

The FDA product code for CBYON SURGICAL OPERATING SYSTEM (SOS) is HAW.

Related Clinical Trials

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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Other records listing Cbyon, Inc. 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.

K012886CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY 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

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

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