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)

LAKE MALE EXTERNAL CATHETERIZATION KIT

K-Number: K902508 · 1990-08-23

ApplicantLake Medical Products, Inc.
Decision Date1990-08-23
Product CodeFCM
Advisory CommitteeGU
DecisionUnknown

Device Summary

LAKE MALE EXTERNAL CATHETERIZATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Lake Medical Products, Inc.. It received FDA 510(k) clearance on 1990-08-23 under 510(k) number K902508. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the LAKE MALE EXTERNAL CATHETERIZATION KIT?

LAKE MALE EXTERNAL CATHETERIZATION KIT is a medical device that received FDA 510(k) clearance on 1990-08-23. The listed applicant is Lake Medical Products, Inc.. The 510(k) number is K902508.

When did LAKE MALE EXTERNAL CATHETERIZATION KIT receive FDA 510(k) clearance?

LAKE MALE EXTERNAL CATHETERIZATION KIT received FDA 510(k) clearance on 1990-08-23, under 510(k) number K902508.

Who is the listed applicant for LAKE MALE EXTERNAL CATHETERIZATION KIT?

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

What is the FDA product code for LAKE MALE EXTERNAL CATHETERIZATION KIT?

The FDA product code for LAKE MALE EXTERNAL CATHETERIZATION KIT 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 Lake 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.

K943162LAKE STAGEZERO(TM) AIR FLOTATION BEDK922730LAKE OSTOMY CARE SETK905053STAGE ZERO AIR FLOTATION BEDK901835LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)K902121LAKE GASTROSTOMY TUBEK884127LAKE N/G FEEDING TUBE

View all 15 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑