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Backstop Catheter

by Pluromed, Inc. 2 variants

510(k) K110491

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 · Special NumberK110491 Date16 Mar 2011ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

A Backstop Catheter is a urological catheter device classified under medical specialty Gastroenterology, Urology. It is a catheter intended for use in urological procedures.

The device received FDA 510(k) clearance (K110491) on March 16, 2011, and is classified as a Class II medical device. It is manufactured by Pluromed, Inc. and is supplied non-sterile for single-use application in clinical settings.

Other devices from Pluromed, Inc.

Questions

AI-generated answers, 23 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 Backstop Catheter used for?

    The Backstop Catheter is a urological catheter device intended for use in urological procedures. It is classified under medical specialties Gastroenterology and Urology, designed for clinical applications in these fields.

  • How is the Backstop Catheter supplied and what is its sterility status?

    The Backstop Catheter is supplied non-sterile and is designed for single-use application in clinical settings. This means it should be used once and then discarded, and appropriate sterilization procedures should be followed before each use.

  • What is the regulatory status of the Backstop Catheter?

    The Backstop Catheter received FDA 510(k) clearance (K110491) on March 16, 2011, and is classified as a Class II medical device. It is manufactured by Pluromed, Inc. and has been determined to be substantially equivalent to other legally marketed devices.

  • Are there different sizes or models of the Backstop Catheter available?

    The device data does not specify different sizes or models of the Backstop Catheter. The information provided indicates it is a single device type manufactured by Pluromed, Inc. for urological procedures.