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Pri a Pus

by Trans Texas Medical Devices Corp.

510(k) K832756

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 NumberK832756 Date28 Nov 1983ClearedStatusActive

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  • Withdrawn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 PRI-A-PUS is an External Penile Rigidity device, designed to assist in the measurement or maintenance of penile rigidity for diagnostic or therapeutic purposes. Classified as a Class II medical device under FDA regulations, it is intended for use in urological assessments and treatments related to erectile function.

This device is supplied as a reusable medical instrument and is regulated under the FDA’s 510(k) clearance process, with a submission date of August 16, 1983, and clearance granted on November 28, 1983. It is intended for clinical use in settings such as urology and gastroenterology, adhering to regulatory standards outlined in CFR Title 21, specifically under regulation number 876.5020. No information regarding sterility or MRI safety is provided in the available data.

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 PRI-A-PUS device used for?

    The PRI-A-PUS is an External Penile Rigidity device designed to measure or maintain penile rigidity for diagnostic or therapeutic purposes. It is primarily used in urological assessments and treatments related to erectile function, helping clinicians evaluate and manage conditions affecting penile rigidity.

  • Is the PRI-A-PUS device single-use or reusable?

    The PRI-A-PUS is supplied as a reusable medical instrument. This design allows for repeated clinical use, provided proper cleaning and maintenance protocols are followed to ensure safety and efficacy between patients.

  • What regulatory approval does the PRI-A-PUS device hold?

    The PRI-A-PUS is regulated under the FDA’s 510(k) clearance process and was granted clearance on November 28, 1983. It is classified as a Class II medical device and adheres to regulatory standards outlined in CFR Title 21, specifically under regulation number 876.5020.

  • In which clinical settings is the PRI-A-PUS device typically used?

    This device is intended for clinical use in settings such as urology and gastroenterology. Its applications include diagnostic evaluations and therapeutic interventions related to erectile function, where assessing penile rigidity is essential.

  • Are there any specific storage instructions for the PRI-A-PUS device?

    While the provided data does not explicitly detail storage instructions, reusable medical devices like the PRI-A-PUS generally require clean, dry storage in a protected environment to prevent contamination or damage. Follow manufacturer guidelines for proper cleaning, disinfection, and maintenance to ensure longevity and safe reuse.