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)

IRRIGATION TUBING SET

K-Number: K921415 · 1992-09-04

ApplicantPsi Medical Products, Inc.
Decision Date1992-09-04
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IRRIGATION TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Psi Medical Products, Inc.. It received FDA 510(k) clearance on 1992-09-04 under 510(k) number K921415. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION TUBING SET?

IRRIGATION TUBING SET is a medical device that received FDA 510(k) clearance on 1992-09-04. The listed applicant is Psi Medical Products, Inc.. The 510(k) number is K921415.

When did IRRIGATION TUBING SET receive FDA 510(k) clearance?

IRRIGATION TUBING SET received FDA 510(k) clearance on 1992-09-04, under 510(k) number K921415.

Who is the listed applicant for IRRIGATION TUBING SET?

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

What is the FDA product code for IRRIGATION TUBING SET?

The FDA product code for IRRIGATION TUBING SET is KOD.

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 Psi Medical Products, 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.

K931779EHL PULSE GENERATORK915459FLOWMATE HAND PUMPK920410EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROBK926423S/2(TM) STOPCOCKK921253INSTRUMENT IRRIGATION PUMPK915458URETEROSCOPE

View all 7 devices →

Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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.

↑