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 INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT

K-Number: K951260 · 1995-09-27

ApplicantBiosearch Medical Products, Inc.
Decision Date1995-09-27
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Biosearch Medical Products, Inc.. It received FDA 510(k) clearance on 1995-09-27 under 510(k) number K951260. 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 URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT?

URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT is a medical device that received FDA 510(k) clearance on 1995-09-27. The listed applicant is Biosearch Medical Products, Inc.. The 510(k) number is K951260.

When did URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT receive FDA 510(k) clearance?

URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT received FDA 510(k) clearance on 1995-09-27, under 510(k) number K951260.

Who is the listed applicant for URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT?

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

What is the FDA product code for URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT?

The FDA product code for URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT 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 Biosearch 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.

K051480ENTERAL FEEDING TUBEK970145PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)K964871BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTSK944614MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEMK932295NON-BALLOON REPLACEMENT GASTROSTOMY KITK935045BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER

View all 70 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.

↑