Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HYDRO-CLENZ UNIT

K-Number: K863539 · 1986-10-16

ApplicantAtlantic Health Group
Decision Date1986-10-16
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HYDRO-CLENZ UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Health Group. It received FDA 510(k) clearance on 1986-10-16 under 510(k) number K863539. 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 HYDRO-CLENZ UNIT?

HYDRO-CLENZ UNIT is a medical device that received FDA 510(k) clearance on 1986-10-16. The listed applicant is Atlantic Health Group. The 510(k) number is K863539.

When did HYDRO-CLENZ UNIT receive FDA 510(k) clearance?

HYDRO-CLENZ UNIT received FDA 510(k) clearance on 1986-10-16, under 510(k) number K863539.

Who is the listed applicant for HYDRO-CLENZ UNIT?

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

What is the FDA product code for HYDRO-CLENZ UNIT?

The FDA product code for HYDRO-CLENZ UNIT 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

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.

↑