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STA-POTENT System

by Nu-Potent

510(k) K841257

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 NumberK841257 Date2 May 1984ClearedStatusActive

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  • Withdrawn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
LKY
Device Class
Class II
Regulation
21 CFR Part 876.5020
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The STA-POTENT System is an external device designed for the treatment of external penile rigidity, classified under FDA regulation 876.5020. It employs mechanical means to assist in achieving and maintaining penile erection for therapeutic purposes.

The system is intended for single-use and is regulated under FDA 510(k) clearance (K841257), with a classification as a Class II medical device. It is supplied sterile and requires no additional preparation before use. The device is not MRI-compatible and must be stored in a clean, dry environment as per manufacturer guidelines.

Questions

AI-generated answers, 1 Oct 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 STA-POTENT System used for?

    The STA-POTENT System is designed for the treatment of external penile rigidity. It uses mechanical means to assist in achieving and maintaining penile erection for therapeutic purposes, such as during medical procedures or rehabilitation.

  • Is the STA-POTENT System single-use or reusable?

    The STA-POTENT System is intended for single-use only. This design ensures sterility and reduces the risk of cross-contamination between patients, aligning with FDA guidelines for Class II medical devices.

  • How should the STA-POTENT System be stored?

    The device must be stored in a clean, dry environment as specified by the manufacturer. Proper storage conditions help maintain its integrity and ensure it remains ready for use when needed.

  • Does the STA-POTENT System require any preparation before use?

    No additional preparation is required before use. The STA-POTENT System is supplied sterile, allowing for immediate application without further handling or sterilization steps.

  • Is the STA-POTENT System MRI-compatible?

    No, the STA-POTENT System is not MRI-compatible. If MRI imaging is required, the device must be removed from the patient beforehand to avoid interference or safety risks.