Cleared Traditional

K043021 - STRYKER URETEROSCOPE

K043021 is an FDA 510(k) clearance for STRYKER URETEROSCOPE, manufactured by Stryker Endoscopy. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K043021 · Stryker Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
133d
Days
Class 2
Risk

K043021 is an FDA 510(k) clearance for the STRYKER URETEROSCOPE. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on March 16, 2005 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Endoscopy devices

FDA 510(k) Submission Details - K043021

510(k) Number K043021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2004
Decision Date March 16, 2005
Days to Decision 133 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 131d · This submission: 133d
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 100
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K043021.
STRYKER VIDEO URETEROSCOPE
K121112 · Stryker Endoscopy · Sep 2012
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
K111480 · Technology Delivery Systems, Inc. · Apr 2012
ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
K052044 · Acmi Corporation · Aug 2005
OLYMPUS VIDEO URETEROSCOPE, NTSC
K033651 · Olympus Winter & Ibe GmbH · Jan 2004
STRYKER FLEXIBLE URETEROSCOPE
K031278 · Stryker Endoscopy · Oct 2003
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
K023358 · Acmi Corporation · Jan 2003