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FDA 510(k)

ENDOLINK TRUE MOVEMENT SYSTEM

K-Number: K043541 · 2005-03-10

ApplicantNovare Surgical Systems, Inc.
Decision Date2005-03-10
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOLINK TRUE MOVEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Novare Surgical Systems, Inc.. It received FDA 510(k) clearance on 2005-03-10 under 510(k) number K043541. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOLINK TRUE MOVEMENT SYSTEM?

ENDOLINK TRUE MOVEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-10. The listed applicant is Novare Surgical Systems, Inc.. The 510(k) number is K043541.

When did ENDOLINK TRUE MOVEMENT SYSTEM receive FDA 510(k) clearance?

ENDOLINK TRUE MOVEMENT SYSTEM received FDA 510(k) clearance on 2005-03-10, under 510(k) number K043541.

Who is the listed applicant for ENDOLINK TRUE MOVEMENT SYSTEM?

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

What is the FDA product code for ENDOLINK TRUE MOVEMENT SYSTEM?

The FDA product code for ENDOLINK TRUE MOVEMENT SYSTEM is GCJ.

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Other records listing Novare Surgical Systems, 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.

K072715REALHAND HIGH DEXTERITY INSTRUMENTSK071488REALHAND HIGH DEXTERITY (HD) INSTRUMENTSK032589ENCLOSE II ANASTOMOSIS ASSIST DEVICEK023682ENCLOSE ANASTOMOSIS ASSIST DEVICEK010727FLEXLINE CLAMPK010694INCLUDER CLAMP

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Related Devices (Code: GCJ)

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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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