Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Foley Balloon Catheter for Urology

K-Number: K201776 · 2020-12-30

ApplicantApollon Co., Ltd.
Decision Date2020-12-30
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Foley Balloon Catheter for Urology is the device name listed in this FDA 510(k) record. The listed applicant is Apollon Co., Ltd.. It received FDA 510(k) clearance on 2020-12-30 under 510(k) number K201776. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Foley Balloon Catheter for Urology?

Foley Balloon Catheter for Urology is a medical device that received FDA 510(k) clearance on 2020-12-30. The listed applicant is Apollon Co., Ltd.. The 510(k) number is K201776.

When did Foley Balloon Catheter for Urology receive FDA 510(k) clearance?

Foley Balloon Catheter for Urology received FDA 510(k) clearance on 2020-12-30, under 510(k) number K201776.

Who is the listed applicant for Foley Balloon Catheter for Urology?

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

What is the FDA product code for Foley Balloon Catheter for Urology?

The FDA product code for Foley Balloon Catheter for Urology is EZL.

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.

NCT07006896Induction of Labor After Cesarean Using Foley Alone vs. Concurrent Foley and OxytocinACTIVE_NOT_RECRUITINGNCT07214948Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor InductionRECRUITINGNCT07782762Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)RECRUITING

Related Devices (Code: EZL)

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.

K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.K240057TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC

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.

↑