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FDA 510(k)

LotusCatheter (Lotus No Balloon Catheter)

K-Number: K191512 · 2020-05-21

ApplicantHakki Medical Technologies, Inc.
Decision Date2020-05-21
Product CodeGBM
Advisory CommitteeGU
DecisionUnknown

Device Summary

LotusCatheter (Lotus No Balloon Catheter) 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 2020-05-21 under 510(k) number K191512. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the LotusCatheter (Lotus No Balloon Catheter)?

LotusCatheter (Lotus No Balloon Catheter) is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Hakki Medical Technologies, Inc.. The 510(k) number is K191512.

When did LotusCatheter (Lotus No Balloon Catheter) receive FDA 510(k) clearance?

LotusCatheter (Lotus No Balloon Catheter) received FDA 510(k) clearance on 2020-05-21, under 510(k) number K191512.

Who is the listed applicant for LotusCatheter (Lotus No Balloon Catheter)?

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 LotusCatheter (Lotus No Balloon Catheter)?

The FDA product code for LotusCatheter (Lotus No Balloon Catheter) is GBM.

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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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