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FDA 510(k)

REALHAND HIGH DEXTERITY INSTRUMENTS

K-Number: K072715 · 2007-10-16

ApplicantNovare Surgical Systems, Inc.
Decision Date2007-10-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REALHAND HIGH DEXTERITY INSTRUMENTS 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 2007-10-16 under 510(k) number K072715. 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 REALHAND HIGH DEXTERITY INSTRUMENTS?

REALHAND HIGH DEXTERITY INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2007-10-16. The listed applicant is Novare Surgical Systems, Inc.. The 510(k) number is K072715.

When did REALHAND HIGH DEXTERITY INSTRUMENTS receive FDA 510(k) clearance?

REALHAND HIGH DEXTERITY INSTRUMENTS received FDA 510(k) clearance on 2007-10-16, under 510(k) number K072715.

Who is the listed applicant for REALHAND HIGH DEXTERITY INSTRUMENTS?

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 REALHAND HIGH DEXTERITY INSTRUMENTS?

The FDA product code for REALHAND HIGH DEXTERITY INSTRUMENTS 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.

K071488REALHAND HIGH DEXTERITY (HD) INSTRUMENTSK043541ENDOLINK TRUE MOVEMENT SYSTEMK032589ENCLOSE II ANASTOMOSIS ASSIST DEVICEK023682ENCLOSE ANASTOMOSIS ASSIST DEVICEK010727FLEXLINE CLAMPK010694INCLUDER CLAMP

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Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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