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Fecal Sanitary Tube

by Leon'S Fecal Sanitary Tub Mfg.

510(k) K813526

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 NumberK813526 Date12 Jan 1982ClearedStatusActive

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  • Withdrawn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
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Fecal Sanitary Tube is a medical device used for fecal collection and handling. It is designed to facilitate the safe and sanitary collection of fecal specimens for laboratory analysis.

The device is supplied as a single-use item and is not intended for reuse. It is regulated under product code KNT and received FDA 510(k) clearance on January 12, 1982, with decision code SESE. The device is manufactured by Leon's Fecal Sanitary Tub Mfg. and is available in various sizes as specified by the manufacturer.

Questions

AI-generated answers, 24 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 Fecal Sanitary Tube used for?

    The Fecal Sanitary Tube is a medical device specifically designed for the safe and sanitary collection of fecal specimens for laboratory analysis. It ensures proper handling during sample collection procedures.

  • Is the Fecal Sanitary Tube reusable or single-use?

    The Fecal Sanitary Tube is supplied as a single-use item and is not intended for reuse. This design prevents cross-contamination between samples and ensures sanitary handling procedures.

  • What sizes are available for the Fecal Sanitary Tube?

    The Fecal Sanitary Tube is available in various sizes as specified by the manufacturer, Leon's Fecal Sanitary Tub Mfg. The specific size options would need to be confirmed with the manufacturer directly.

  • What regulatory clearance does the Fecal Sanitary Tube have?

    The Fecal Sanitary Tube is regulated under product code KNT and received FDA 510(k) clearance on January 12, 1982, with decision code SESE, indicating it is substantially equivalent to predicate devices.