Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

URINARY CARE SUPPLIES

K-Number: K923496 · 1993-05-27

ApplicantOrion Life Systems, Inc.
Decision Date1993-05-27
Product CodeKNY
Advisory CommitteeGU
DecisionUnknown

Device Summary

URINARY CARE SUPPLIES is the device name listed in this FDA 510(k) record. The listed applicant is Orion Life Systems, Inc.. It received FDA 510(k) clearance on 1993-05-27 under 510(k) number K923496. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the URINARY CARE SUPPLIES?

URINARY CARE SUPPLIES is a medical device that received FDA 510(k) clearance on 1993-05-27. The listed applicant is Orion Life Systems, Inc.. The 510(k) number is K923496.

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

URINARY CARE SUPPLIES received FDA 510(k) clearance on 1993-05-27, under 510(k) number K923496.

Who is the listed applicant for URINARY CARE SUPPLIES?

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

What is the FDA product code for URINARY CARE SUPPLIES?

The FDA product code for URINARY CARE SUPPLIES is KNY.

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 Orion Life Systems, 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.

K943835PRE-FILLED SYRINGE W/STERILE .25% ACETC ACIDK943831PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATERK943832STERILE .9% SODIUM CHLORIDE FOR IRRATIONK943828STERILE WATER FOR IRRIGATIONK943834STERILE .9% SODIUM CHLORIDE SOLUTIONK943830PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION

View all 33 devices →

Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

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.

↑