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FDA 510(k)

HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH

K-Number: K101900 · 2011-02-07

ApplicantHakki Medical Technologies, Inc.
Decision Date2011-02-07
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH is the device name listed in this FDA 510(k) record. The listed applicant is Hakki Medical Technologies, Inc.. It received FDA 510(k) clearance on 2011-02-07 under 510(k) number K101900. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH?

HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH is a medical device that received FDA 510(k) clearance on 2011-02-07. The listed applicant is Hakki Medical Technologies, Inc.. The 510(k) number is K101900.

When did HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH receive FDA 510(k) clearance?

HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH received FDA 510(k) clearance on 2011-02-07, under 510(k) number K101900.

Who is the listed applicant for HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH?

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

What is the FDA product code for HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH?

The FDA product code for HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH is GBM.

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 Hakki Medical Technologies, 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.

K191512LotusCatheter (Lotus No Balloon Catheter)

Related Devices (Code: GBM)

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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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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