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FDA 510(k)

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10

K-Number: K152834 · 2016-08-10

ApplicantColonplus Equipments & Speculums, S.L.
Decision Date2016-08-10
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 is a medical device manufactured by Colonplus Equipments & Speculums, S.L.. It received FDA 510(k) clearance on 2016-08-10 under approval number K152834. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10?

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 is a medical device that received FDA 510(k) clearance on 2016-08-10. It is manufactured by Colonplus Equipments & Speculums, S.L.. The 510(k) number is K152834.

When was Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 approved by the FDA?

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 received FDA 510(k) clearance on 2016-08-10, under approval number K152834.

What company makes Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10?

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 is manufactured by Colonplus Equipments & Speculums, S.L..

What is the FDA product code for Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10?

The FDA product code for Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 is KPL.

Related Clinical Trials

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Related Devices (Code: KPL)

K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic Plus K201861Bio Fluff SystemGnali Bocia S.R.L.

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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