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Judd Urethal Catheter Container

by Phil Judd, Inc.

510(k) K864592

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK864592 Date24 Jun 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 19 Sep 2026

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

The Judd Urethral Catheter Container is a sterile packaging system designed to protect and preserve urethral catheters during storage and transport. It is classified as a urological catheter container, ensuring the catheter remains uncontaminated and ready for clinical use.

This device is intended for single-use in clinical settings, such as hospitals and medical facilities, where sterile conditions are required. Supplied in a sterile, sealed container, it adheres to FDA 510(k) clearance (K864592) and regulatory standards for urological devices. The container is non-reusable and must be stored in a clean, dry environment to maintain sterility.

Questions

AI-generated answers, 19 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 primary purpose of the Judd Urethral Catheter Container, and how does it ensure catheter sterility during storage and transport?

    The Judd Urethral Catheter Container is designed as a sterile packaging system specifically to protect and preserve urethral catheters during storage and transport. It maintains catheter sterility by keeping the device sealed and uncontaminated, ensuring it remains ready for single-use in clinical settings like hospitals. The sealed, sterile packaging prevents exposure to environmental contaminants, which is critical for maintaining aseptic conditions before use.

  • Is the Judd Urethral Catheter Container reusable, or is it intended for single-use only?

    The Judd Urethral Catheter Container is explicitly intended for single-use only. This design ensures patient safety by preventing cross-contamination between uses, as reusing the container could compromise its sterility and integrity. After opening or use, the container must be discarded to comply with clinical protocols.

  • What storage conditions are required to maintain the sterility of the Judd Urethral Catheter Container?

    To preserve sterility, the container must be stored in a clean, dry environment away from direct sunlight, moisture, or extreme temperatures. The sealed packaging should remain intact until immediate use, as any breach could introduce contaminants. Proper storage adheres to the manufacturer’s guidelines to ensure the catheter remains uncontaminated and ready for clinical application.

  • How do I confirm the regulatory compliance of the Judd Urethral Catheter Container before purchasing or using it?

    The Judd Urethral Catheter Container holds FDA 510(k) clearance (K864592), confirming it meets U.S. regulatory standards for urological devices. The clearance was granted under the Gastroenterology and Urology (GU) Advisory Committee and classified as substantially equivalent to predicate devices. Always verify the clearance number and regulatory route (e.g., 510(k)) with the manufacturer or FDA’s database to ensure compliance with current requirements.