Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ENCLOSE ANASTOMOSIS ASSIST DEVICE

K-Number: K023682 · 2003-01-16

ApplicantNovare Surgical Systems, Inc.
Decision Date2003-01-16
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENCLOSE 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 2003-01-16 under 510(k) number K023682. 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 ANASTOMOSIS ASSIST DEVICE?

ENCLOSE ANASTOMOSIS ASSIST DEVICE is a medical device that received FDA 510(k) clearance on 2003-01-16. The listed applicant is Novare Surgical Systems, Inc.. The 510(k) number is K023682.

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

ENCLOSE ANASTOMOSIS ASSIST DEVICE received FDA 510(k) clearance on 2003-01-16, under 510(k) number K023682.

Who is the listed applicant for ENCLOSE 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 ANASTOMOSIS ASSIST DEVICE?

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

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK032589ENCLOSE II ANASTOMOSIS ASSIST DEVICEK010727FLEXLINE CLAMPK010694INCLUDER CLAMP

View all 9 devices →

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.

↑