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FDA 510(k)

URINARY GEL DRAINAGE SYSTEM

K-Number: K952780 · 1995-12-12

ApplicantP.A.M., Inc.
Decision Date1995-12-12
Product CodeEYZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINARY GEL DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is P.A.M., Inc.. It received FDA 510(k) clearance on 1995-12-12 under 510(k) number K952780. The device is classified under product code EYZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINARY GEL DRAINAGE SYSTEM?

URINARY GEL DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1995-12-12. The listed applicant is P.A.M., Inc.. The 510(k) number is K952780.

When did URINARY GEL DRAINAGE SYSTEM receive FDA 510(k) clearance?

URINARY GEL DRAINAGE SYSTEM received FDA 510(k) clearance on 1995-12-12, under 510(k) number K952780.

Who is the listed applicant for URINARY GEL DRAINAGE SYSTEM?

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

What is the FDA product code for URINARY GEL DRAINAGE SYSTEM?

The FDA product code for URINARY GEL DRAINAGE SYSTEM is EYZ.

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

Related Devices (Code: EYZ)

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.

K964219ZIP CONDOM CATHETERGoulter Medical, Inc.K961906UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018Spectrum Medsystems Corp.K951597URINARY DRAINAGE BAGKey Medical Services, Inc.K942753ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINERResearched, Novel Medical Devices (Rn/Md)K933126COMFORTCARE SYSTEMPatsy J. Trisler, J.D.K930556NIGHT URINARY DRAINAGE BEDSIDE BAGEzmt Valve Co., 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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