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FDA 510(k)

ENCLOSE II ANASTOMOSIS ASSIST DEVICE

K-Number: K032589 · 2003-09-05

ApplicantNovare Surgical Systems, Inc.
Decision Date2003-09-05
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENCLOSE II ANASTOMOSIS ASSIST DEVICE 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 2003-09-05 under 510(k) number K032589. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCLOSE II ANASTOMOSIS ASSIST DEVICE?

ENCLOSE II ANASTOMOSIS ASSIST DEVICE is a medical device that received FDA 510(k) clearance on 2003-09-05. The listed applicant is Novare Surgical Systems, Inc.. The 510(k) number is K032589.

When did ENCLOSE II ANASTOMOSIS ASSIST DEVICE receive FDA 510(k) clearance?

ENCLOSE II ANASTOMOSIS ASSIST DEVICE received FDA 510(k) clearance on 2003-09-05, under 510(k) number K032589.

Who is the listed applicant for ENCLOSE II ANASTOMOSIS ASSIST DEVICE?

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 ENCLOSE II ANASTOMOSIS ASSIST DEVICE?

The FDA product code for ENCLOSE II ANASTOMOSIS ASSIST DEVICE is DXC.

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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) INSTRUMENTSK043541ENDOLINK TRUE MOVEMENT SYSTEMK023682ENCLOSE ANASTOMOSIS ASSIST DEVICEK010727FLEXLINE CLAMPK010694INCLUDER CLAMP

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Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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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