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FDA 510(k)

URINE COLLECTOR & ACCESSORIES

K-Number: K945204 · 1994-11-02

ApplicantNelmed Corp.
Decision Date1994-11-02
Product CodeFAQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINE COLLECTOR & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Nelmed Corp.. It received FDA 510(k) clearance on 1994-11-02 under 510(k) number K945204. The device is classified under product code FAQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE COLLECTOR & ACCESSORIES?

URINE COLLECTOR & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1994-11-02. The listed applicant is Nelmed Corp.. The 510(k) number is K945204.

When did URINE COLLECTOR & ACCESSORIES receive FDA 510(k) clearance?

URINE COLLECTOR & ACCESSORIES received FDA 510(k) clearance on 1994-11-02, under 510(k) number K945204.

Who is the listed applicant for URINE COLLECTOR & ACCESSORIES?

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

What is the FDA product code for URINE COLLECTOR & ACCESSORIES?

The FDA product code for URINE COLLECTOR & ACCESSORIES is FAQ.

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 Nelmed Corp. 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.

K934772GASTRONOMY TUBE HOLDER

Related Devices (Code: FAQ)

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.

K962604PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZINGConvatec, A Division of E.R. Squibb & SonsK960217CPR URINE BAGCustom Pack ReliabilityK955609CONVEEN URINE BAG - STERILEColoplast Corp.K953767PROSYS BEDSIDE DRAINAGE BAGConvatec, A Division of E.R. Squibb & SonsK953783CONVEEN LEG BAG STRAPColoplast Corp.K951945PROSYS LEG BAGConvatec, A Division of E.R. Squibb & Sons

Official Source

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