FDA 510(k)

DOUCHE UNIT-1500 ML DISP. CONTAINER

K-Number: K800957 · 1980-07-14

ApplicantThe Healthcare Group Laboratories, Inc.

Decision Date1980-07-14

Product CodeHED

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

DOUCHE UNIT-1500 ML DISP. CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is The Healthcare Group Laboratories, Inc.. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K800957. The device is classified under product code HED. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOUCHE UNIT-1500 ML DISP. CONTAINER?

DOUCHE UNIT-1500 ML DISP. CONTAINER is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is The Healthcare Group Laboratories, Inc.. The 510(k) number is K800957.

When did DOUCHE UNIT-1500 ML DISP. CONTAINER receive FDA 510(k) clearance?

DOUCHE UNIT-1500 ML DISP. CONTAINER received FDA 510(k) clearance on 1980-07-14, under 510(k) number K800957.

Who is the listed applicant for DOUCHE UNIT-1500 ML DISP. CONTAINER?

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

What is the FDA product code for DOUCHE UNIT-1500 ML DISP. CONTAINER?

The FDA product code for DOUCHE UNIT-1500 ML DISP. CONTAINER is HED.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing The Healthcare Group Laboratories, Inc. as applicant

K850035EMPTY SOLUTION TRANSFER CONTAINER K842170EMPTY SOLUTION TRANSFER CONTAINER K842091DISPOS. ACU-CUT SOFT TISSUE BIOPSY K840742RIGHT ATRIAL CATHETER K830299SOLUTION TRANSFER CONTAINER K822307ADHESIVE SPRAY #4050-4060

View all 29 devices →

Related Devices (Code: HED)

K080200WATER WORKS DOUCHING DEVICEAbbott Research Group, Inc.K030056WORRY-REMOVER IRRIGATORCorisen Group, Ltd.K000736LA JOIEGoomi Ehwa, Inc.K902830PERI-BOTTLEOrion Life Systems, Inc.K881216GENT-L-KARE VAGINAL IRRIGATION SETGeneva Laboratories, Inc.K854595P.A. MEDICAL VAGINAL IRRIGATION SET #1130Pa Medical Corp.

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.