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FDA 510(k)

NIR LAT MALE EXTERNAL CATHETER

K-Number: K855209 · 1986-01-10

ApplicantMali, Inc.
Decision Date1986-01-10
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NIR LAT MALE EXTERNAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mali, Inc.. It received FDA 510(k) clearance on 1986-01-10 under 510(k) number K855209. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIR LAT MALE EXTERNAL CATHETER?

NIR LAT MALE EXTERNAL CATHETER is a medical device that received FDA 510(k) clearance on 1986-01-10. The listed applicant is Mali, Inc.. The 510(k) number is K855209.

When did NIR LAT MALE EXTERNAL CATHETER receive FDA 510(k) clearance?

NIR LAT MALE EXTERNAL CATHETER received FDA 510(k) clearance on 1986-01-10, under 510(k) number K855209.

Who is the listed applicant for NIR LAT MALE EXTERNAL CATHETER?

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

What is the FDA product code for NIR LAT MALE EXTERNAL CATHETER?

The FDA product code for NIR LAT MALE EXTERNAL CATHETER is KNX.

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 Mali, 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.

K864176GENTLE FEEL

Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.

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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