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FDA 510(k)

4 SURE URINARY LEG BAG

K-Number: K896728 · 1990-02-20

ApplicantThe Boston & Pacific Co., Inc.
Decision Date1990-02-20
Product CodeFAQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4 SURE URINARY LEG BAG is the device name listed in this FDA 510(k) record. The listed applicant is The Boston & Pacific Co., Inc.. It received FDA 510(k) clearance on 1990-02-20 under 510(k) number K896728. 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 4 SURE URINARY LEG BAG?

4 SURE URINARY LEG BAG is a medical device that received FDA 510(k) clearance on 1990-02-20. The listed applicant is The Boston & Pacific Co., Inc.. The 510(k) number is K896728.

When did 4 SURE URINARY LEG BAG receive FDA 510(k) clearance?

4 SURE URINARY LEG BAG received FDA 510(k) clearance on 1990-02-20, under 510(k) number K896728.

Who is the listed applicant for 4 SURE URINARY LEG BAG?

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

What is the FDA product code for 4 SURE URINARY LEG BAG?

The FDA product code for 4 SURE URINARY LEG BAG 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 The Boston & Pacific Co., 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.

K8967264 SURE EXTERNAL MALE CATHETERK8967274 SURE URINARY DRAIN BAGK8967254 SURE UROLOGICAL CATHETER

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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