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FDA 510(k)

URINARY CATHETER CARE SET

K-Number: K780735 · 1978-06-13

ApplicantShield Laboratories, Inc.
Decision Date1978-06-13
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINARY CATHETER CARE SET is the device name listed in this FDA 510(k) record. The listed applicant is Shield Laboratories, Inc.. It received FDA 510(k) clearance on 1978-06-13 under 510(k) number K780735. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINARY CATHETER CARE SET?

URINARY CATHETER CARE SET is a medical device that received FDA 510(k) clearance on 1978-06-13. The listed applicant is Shield Laboratories, Inc.. The 510(k) number is K780735.

When did URINARY CATHETER CARE SET receive FDA 510(k) clearance?

URINARY CATHETER CARE SET received FDA 510(k) clearance on 1978-06-13, under 510(k) number K780735.

Who is the listed applicant for URINARY CATHETER CARE SET?

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

What is the FDA product code for URINARY CATHETER CARE SET?

The FDA product code for URINARY CATHETER CARE SET is FCM.

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 Shield Laboratories, 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.

K771712CATHETER DRESSING CHANCE SET

Related Devices (Code: FCM)

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.

K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec LimitedK223821Self-Cath Closed SystemColoplastK082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLCK070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, Inc.

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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