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)

SPECTRUM SILICONE FOLEY CATHETER

K-Number: K000251 · 2000-08-30

ApplicantCook Urological, Inc.
Decision Date2000-08-30
Product CodeMJC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPECTRUM SILICONE FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2000-08-30 under 510(k) number K000251. The device is classified under product code MJC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM SILICONE FOLEY CATHETER?

SPECTRUM SILICONE FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 2000-08-30. The listed applicant is Cook Urological, Inc.. The 510(k) number is K000251.

When did SPECTRUM SILICONE FOLEY CATHETER receive FDA 510(k) clearance?

SPECTRUM SILICONE FOLEY CATHETER received FDA 510(k) clearance on 2000-08-30, under 510(k) number K000251.

Who is the listed applicant for SPECTRUM SILICONE FOLEY CATHETER?

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

What is the FDA product code for SPECTRUM SILICONE FOLEY CATHETER?

The FDA product code for SPECTRUM SILICONE FOLEY CATHETER is MJC.

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 Cook Urological, 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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLE

View all 104 devices →

Related Devices (Code: MJC)

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.

K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd.K040658BARDEX I.C. LATEX FOLEY CATHETERC.R. Bard, Inc.K033477HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KITRochester Medical Corp.K001143RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETERRochester Medical Corp.K993464BARDEX I.C. PEDIATRIC FOLEY CATHETERC.R. Bard, Inc.K984136BARDEX LUBRI-SIL I.C. FOLEY CATHETERBard Medical Div.

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.

↑