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Curity 100% Silicone Coude' Catheter

by The Kendal Co.

510(k) K833790

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

17 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833790 Date27 Dec 1983ClearedStatusActive

Recalls

17 recalls · FDA

  • 17 recalls, same reason

    • Terminated Z-1212-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1219-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1223-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1218-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1227-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1209-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1224-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1206-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1226-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1229-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1220-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1228-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1221-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1211-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1225-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1216-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790
    • Terminated Z-1217-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K833790

    Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KOD
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a urological catheter, specifically a coudé catheter, made of 100% silicone. It is a flexible tubular device designed for insertion through the urethra to pass fluids to or from the urinary tract.

It is supplied as a sterile, single-use device intended for use in clinical settings. The device has received FDA 510(k) clearance (K833790) and is classified as a Class II medical device under product code KOD, with regulation number 876.5130. It is not MRI safe unless explicitly stated, and no reusability, size, or storage details are provided in the data.

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Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CURITY 100% Silicone Coude Catheter used for?

    It is a urological catheter designed for insertion through the urethra to pass fluids to or from the urinary tract, specifically shaped as a coudé tip to navigate anatomical obstructions in the male urethra.

  • Is the CURITY 100% Silicone Coude Catheter sterile and single-use?

    Yes, it is supplied as a sterile, single-use device intended for clinical settings, meaning it is designed for one-time use only and should be discarded after each procedure to prevent cross-contamination.

  • What regulatory clearance does the CURITY 100% Silicone Coude Catheter have?

    It has received FDA 510(k) clearance under submission K833790, is classified as a Class II medical device, and is regulated under product code KOD and regulation number 876.5130 for urological catheters.