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FDA 510(k)

GC IRRIGATOR

K-Number: K980868 · 1998-08-06

ApplicantGentle Colonics, Inc.
Decision Date1998-08-06
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GC IRRIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Gentle Colonics, Inc.. It received FDA 510(k) clearance on 1998-08-06 under 510(k) number K980868. 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 GC IRRIGATOR?

GC IRRIGATOR is a medical device that received FDA 510(k) clearance on 1998-08-06. The listed applicant is Gentle Colonics, Inc.. The 510(k) number is K980868.

When did GC IRRIGATOR receive FDA 510(k) clearance?

GC IRRIGATOR received FDA 510(k) clearance on 1998-08-06, under 510(k) number K980868.

Who is the listed applicant for GC IRRIGATOR?

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

What is the FDA product code for GC IRRIGATOR?

The FDA product code for GC IRRIGATOR is KPL.

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 Gentle Colonics, 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.

K002102GENTLE COLONICS IRRIGATION SYSTEM

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

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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