Skip to content

Ureteroscope

by Psi Medical Products, Inc.

510(k) K915458

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 NumberK915458 Date30 Jan 1992ClearedStatusActive

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  • Withdrawn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
FGB
Device Class
Class II
Regulation
21 CFR Part 876.1500
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.

A ureteroscope is an endoscope used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. This device is classified under product code FGB and is intended for use in gastroenterology and urology procedures.

The ureteroscope is manufactured by Psi Medical Products, Inc. and received FDA 510(k) clearance on January 30, 1992, with K number K915458. It is a class II device regulated under 21 CFR 876.1500. The device is available in various models as indicated by the multiple registration numbers provided in the device data.

Other devices from Psi Medical Products, Inc.

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 a ureteroscope used for?

    A ureteroscope is an endoscope designed to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. It is specifically intended for use in gastroenterology and urology procedures.

  • How is the ureteroscope supplied and what are its sterility requirements?

    The device data does not specify supply details or sterility requirements. The ureteroscope is available in various models as indicated by the multiple registration numbers provided, but specific information on packaging, sterilization methods, or single-use versus reuse status is not included in the provided data.

  • What regulatory status does this ureteroscope have?

    This ureteroscope received FDA 510(k) clearance on January 30, 1992, with K number K915458. It is classified as a class II device regulated under 21 CFR 876.1500 and is manufactured by Psi Medical Products, Inc.

  • Are there different models or sizes available for this ureteroscope?

    Yes, the ureteroscope is available in various models as indicated by the multiple registration numbers provided in the device data. However, the specific differences between models, including sizes or technical specifications, are not detailed in the provided information.