Cleared Traditional

URETEROSCOPE (K915458) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915458 · Psi Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
57d
Days
Class 2
Risk

K915458 is an FDA 510(k) clearance for the URETEROSCOPE. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Psi Medical Products, Inc. (Norwalk, US). The FDA issued a Cleared decision on January 30, 1992 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Psi Medical Products, Inc. devices

Submission Details

510(k) Number K915458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1991
Decision Date January 30, 1992
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGB Ureteroscope And Accessories, Flexible/rigid

All 71
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K915458.
THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
K925128 · KARL STORZ Endoscopy-America, Inc. · Aug 1993
BARD 7 FR. FIBER OPTIC ASSEMBLY
K923545 · C.R. Bard, Inc. · Oct 1992
BARD URETEROSCOPE DEFLECTION MODULE
K920750 · C.R. Bard, Inc. · Apr 1992
BARD 3000 PLUS URETEROSCOPY SYSTEM
K911411 · C.R. Bard, Inc. · Apr 1991
BARD SHORT RIGID URETEROSCOPE
K900813 · C.R. Bard, Inc. · May 1990
BARD URETEROSCOPIC DEVICE
K883110 · C.R. Bard, Inc. · Oct 1988