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FDA 510(k)

COLOSTOMY ENEMA DEVICE

K-Number: K790749 · 1979-05-16

ApplicantVabar Corp.
Decision Date1979-05-16
Product CodeEXD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLOSTOMY ENEMA DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Vabar Corp.. It received FDA 510(k) clearance on 1979-05-16 under 510(k) number K790749. The device is classified under product code EXD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLOSTOMY ENEMA DEVICE?

COLOSTOMY ENEMA DEVICE is a medical device that received FDA 510(k) clearance on 1979-05-16. The listed applicant is Vabar Corp.. The 510(k) number is K790749.

When did COLOSTOMY ENEMA DEVICE receive FDA 510(k) clearance?

COLOSTOMY ENEMA DEVICE received FDA 510(k) clearance on 1979-05-16, under 510(k) number K790749.

Who is the listed applicant for COLOSTOMY ENEMA DEVICE?

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

What is the FDA product code for COLOSTOMY ENEMA DEVICE?

The FDA product code for COLOSTOMY ENEMA DEVICE is EXD.

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 Vabar Corp. 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.

K790750COLOSTOMY DEVICE W/ PRESSURE LID

Related Devices (Code: EXD)

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.

K121833OSTOMY IRRIGATION SETColoplast A/SK914692URINARY DIVERSION EVACUATING CATHETERCook Urological, Inc.K904586PALEX IRRIGATION SETPalex Intl. SAK871791BLOXOM IRRIGATORI.B. Bloxom C/O Hogan & HartsonK840268IRRIGATION SYSTEMColoplast A/SK832299VISI-FLOW IRRIGATORConvatec, A Division of E.R. Squibb & Sons

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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