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)

KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH

K-Number: K881667 · 1988-08-12

ApplicantThe Kendal Co.
Decision Date1988-08-12
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH is the device name listed in this FDA 510(k) record. The listed applicant is The Kendal Co.. It received FDA 510(k) clearance on 1988-08-12 under 510(k) number K881667. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH?

KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH is a medical device that received FDA 510(k) clearance on 1988-08-12. The listed applicant is The Kendal Co.. The 510(k) number is K881667.

When did KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH receive FDA 510(k) clearance?

KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH received FDA 510(k) clearance on 1988-08-12, under 510(k) number K881667.

Who is the listed applicant for KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH?

The FDA 510(k) record lists The Kendal Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH?

The FDA product code for KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH is GBM.

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 The Kendal Co. 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.

K000087MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FRK990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946CK991758MONOJECT INSULIN SYRINGEK970969KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SETK951488KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAPK942664KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM

View all 63 devices →

Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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.

↑