Cleared Traditional

K901214 - RIGID URETEROSCOPE

K901214 is an FDA 510(k) clearance for RIGID URETEROSCOPE, manufactured by Applied Urology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K901214 · Applied Urology, Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
79d
Days
Class 2
Risk

K901214 is an FDA 510(k) clearance for the RIGID URETEROSCOPE. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Applied Urology, Inc. (Launa Hills, US). The FDA issued a Cleared decision on June 1, 1990 after a review of 79 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 Applied Urology, Inc. devices

FDA 510(k) Submission Details - K901214

510(k) Number K901214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1990
Decision Date June 01, 1990
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 130d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGB Device Classification - Class 2, Special Controls

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 90
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K901214.
BARD 3000 PLUS URETEROSCOPY SYSTEM
K911411 · C.R. Bard, Inc. · Apr 1991
SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)
K904793 · Surgitek · Mar 1991
SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET
K902773 · Medical Engineering Corp. · Jul 1990
BARD SHORT RIGID URETEROSCOPE
K900813 · C.R. Bard, Inc. · May 1990
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
K884153 · Candela Laser Corp. · Dec 1988
BARD URETEROSCOPIC DEVICE
K883110 · C.R. Bard, Inc. · Oct 1988