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FDA 510(k)

COLON CAR 1.2

K-Number: K042674 · 2004-10-19

ApplicantMedicsight
Decision Date2004-10-19
Product CodeNWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COLON CAR 1.2 is the device name listed in this FDA 510(k) record. The listed applicant is Medicsight. It received FDA 510(k) clearance on 2004-10-19 under 510(k) number K042674. The device is classified under product code NWE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLON CAR 1.2?

COLON CAR 1.2 is a medical device that received FDA 510(k) clearance on 2004-10-19. The listed applicant is Medicsight. The 510(k) number is K042674.

When did COLON CAR 1.2 receive FDA 510(k) clearance?

COLON CAR 1.2 received FDA 510(k) clearance on 2004-10-19, under 510(k) number K042674.

Who is the listed applicant for COLON CAR 1.2?

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

What is the FDA product code for COLON CAR 1.2?

The FDA product code for COLON CAR 1.2 is NWE.

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 Medicsight 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.

K041807LUNG CAR 1.1K033412MEDICLUNG, RELEASE 1K032823MEDICHEART, MODEL RELEASE 1K033102MEDIC COLON MODEL, RELEASE 1

Related Devices (Code: NWE)

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.

K083423COLONCAD API 3.1Medicsight PlcK042605COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITYSiemens AG Medical Solutions

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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