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FDA 510(k)

MEDIPLUS SINGLE USE GI MANOMETRY CATHETER

K-Number: K013704 · 2002-08-05

ApplicantMediplus , Ltd.
Decision Date2002-08-05
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDIPLUS SINGLE USE GI MANOMETRY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mediplus , Ltd.. It received FDA 510(k) clearance on 2002-08-05 under 510(k) number K013704. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIPLUS SINGLE USE GI MANOMETRY CATHETER?

MEDIPLUS SINGLE USE GI MANOMETRY CATHETER is a medical device that received FDA 510(k) clearance on 2002-08-05. The listed applicant is Mediplus , Ltd.. The 510(k) number is K013704.

When did MEDIPLUS SINGLE USE GI MANOMETRY CATHETER receive FDA 510(k) clearance?

MEDIPLUS SINGLE USE GI MANOMETRY CATHETER received FDA 510(k) clearance on 2002-08-05, under 510(k) number K013704.

Who is the listed applicant for MEDIPLUS SINGLE USE GI MANOMETRY CATHETER?

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

What is the FDA product code for MEDIPLUS SINGLE USE GI MANOMETRY CATHETER?

The FDA product code for MEDIPLUS SINGLE USE GI MANOMETRY CATHETER is KLA.

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.

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Other records listing Mediplus , Ltd. 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.

K131339CAPNOMASKK031617MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER

Related Devices (Code: KLA)

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.

K242666Fecobionics Anorectal SystemGi Bionics, LLCK242304REDNeuraxis, Inc.K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp.K180135THD Anopress with THD SensyProbeThd SpaK161785THD ANOPRESSThd SpaK120088MCOMPASS ANORECTAL MANOMETRY SYSTEMMedspira, LLC

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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