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FDA 510(k)

COLON IRRIGATION UNIT

K-Number: K840613 · 1984-07-17

ApplicantColenz Co.
Decision Date1984-07-17
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLON IRRIGATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Colenz Co.. It received FDA 510(k) clearance on 1984-07-17 under 510(k) number K840613. 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 COLON IRRIGATION UNIT?

COLON IRRIGATION UNIT is a medical device that received FDA 510(k) clearance on 1984-07-17. The listed applicant is Colenz Co.. The 510(k) number is K840613.

When did COLON IRRIGATION UNIT receive FDA 510(k) clearance?

COLON IRRIGATION UNIT received FDA 510(k) clearance on 1984-07-17, under 510(k) number K840613.

Who is the listed applicant for COLON IRRIGATION UNIT?

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

What is the FDA product code for COLON IRRIGATION UNIT?

The FDA product code for COLON IRRIGATION UNIT is KPL.

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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.K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic PlusK152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10Colonplus Equipments & Speculums, S.L.K094022THE WATER LILYClearwater Products, LLCK071057COLONIC & ENEMA NOZZLETiller Mind Body, Inc.K051344COLONIC AND ENEMA NOZZLEUltimate Concepts, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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