Cleared Traditional

K121112 - STRYKER VIDEO URETEROSCOPE

K121112 is the FDA 510(k) clearance for STRYKER VIDEO URETEROSCOPE by Stryker Endoscopy. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K121112 · Stryker Endoscopy · Gastroenterology & Urology device
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Sep 2012
Decision
153d
Days
Class 2
Risk

K121112 is an FDA 510(k) clearance for the STRYKER VIDEO 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 September 12, 2012 after a review of 153 days - an extended review 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: 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

Submission Details

510(k) Number K121112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2012
Decision Date September 12, 2012
Days to Decision 153 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
23d slower than avg
Panel avg: 130d · This submission: 153d
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 80
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K121112.
Flexible Video-Uretero-Choledochoscope System
K142556 · KARL STORZ Endoscopy-America, Inc. · Oct 2014
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K141250 · KARL STORZ Endoscopy-America, Inc. · Jun 2014
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K131369 · KARL STORZ Endoscopy-America, Inc. · Nov 2013
STRYKER URETEROSCOPE
K043021 · Stryker Endoscopy · Mar 2005
STRYKER FLEXIBLE URETEROSCOPE
K031278 · Stryker Endoscopy · Oct 2003
FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253
K991178 · Richard Wolf Medical Instruments Corp. · Jun 1999