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FDA 510(k)

Colonic Plus Regular, Small, and Straight Shape Hydrokit

K-Number: K180800 · 2018-06-01

ApplicantColonic Plus
Decision Date2018-06-01
Product CodeKPL
Advisory CommitteeGU
DecisionUnknown

Device Summary

Colonic Plus Regular, Small, and Straight Shape Hydrokit is the device name listed in this FDA 510(k) record. The listed applicant is Colonic Plus. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180800. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Colonic Plus Regular, Small, and Straight Shape Hydrokit?

Colonic Plus Regular, Small, and Straight Shape Hydrokit is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Colonic Plus. The 510(k) number is K180800.

When did Colonic Plus Regular, Small, and Straight Shape Hydrokit receive FDA 510(k) clearance?

Colonic Plus Regular, Small, and Straight Shape Hydrokit received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180800.

Who is the listed applicant for Colonic Plus Regular, Small, and Straight Shape Hydrokit?

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

What is the FDA product code for Colonic Plus Regular, Small, and Straight Shape Hydrokit?

The FDA product code for Colonic Plus Regular, Small, and Straight Shape Hydrokit is KPL.

Related Devices (Code: KPL)

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.

K201861Bio Fluff SystemGnali Bocia S.R.L.K152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10Colonplus Equipments & Speculums, S.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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