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Simplastic Supra Pubic Catheter

by Franklin Medical USA, Inc.

510(k) K852200

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852200 Date7 Aug 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
KOB
Device Class
Class II
Regulation
21 CFR Part 876.5090
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 Simplastic Supra Pubic Catheter is a suprapubic catheter designed for urinary drainage. It is intended for use in patients requiring long-term urinary catheterization, providing a means to bypass the urethra and drain urine directly from the bladder via a stoma in the lower abdomen.

This device is supplied as a sterile, single-use catheter and is classified as a Class II medical device under FDA regulations. It is intended for use in clinical settings such as hospitals and urology clinics, with sizes and configurations tailored for suprapubic insertion. The device holds an FDA 510(k) clearance (K852200) with a decision of Substantially Equivalent, ensuring compliance with regulatory standards for urinary drainage catheters.

Other devices from Franklin Medical USA, Inc.

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 types of clinical settings is the Simplastic Supra Pubic Catheter intended for use in?

    The Simplastic Supra Pubic Catheter is designed for use in clinical environments such as hospitals and urology clinics, where long-term urinary drainage is required. Its suprapubic design allows for bypassing the urethra, making it suitable for patients needing extended catheterization in controlled medical settings.

  • Is the Simplastic Supra Pubic Catheter reusable or intended for single-use only?

    The Simplastic Supra Pubic Catheter is supplied as a sterile, single-use device. This ensures patient safety and hygiene, as it is not intended for reuse after initial use.

  • What regulatory pathway was followed for the FDA clearance of this device?

    The Simplastic Supra Pubic Catheter received FDA clearance through a 510(k) submission, classified as a Traditional review with a Substantially Equivalent (SESE) determination. The device was reviewed by the Gastroenterology and Urology (GU) Advisory Committee and holds clearance number K852200, confirming compliance with regulatory standards for suprapubic catheters.

  • Are there multiple sizes or configurations available for this catheter?

    While the exact sizes and configurations are not detailed in the provided data, the Simplastic Supra Pubic Catheter is designed with suprapubic insertion in mind, implying availability of tailored options to accommodate different patient anatomies. For precise sizing, refer to the manufacturer’s product documentation or catalog.

  • How should the Simplastic Supra Pubic Catheter be stored before use?

    As a sterile, single-use device, the Simplastic Supra Pubic Catheter should be stored in its original packaging in a clean, dry environment, protected from contamination and extreme temperatures. Always follow the manufacturer’s storage instructions to maintain sterility until use.