Cleared Traditional

K982905 - MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE

K982905 is the FDA 510(k) clearance for MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE by Karl Storz Endoscopy. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K982905 · Karl Storz Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
48d
Days
Class 2
Risk

K982905 is an FDA 510(k) clearance for the MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on October 5, 1998 after a review of 48 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 Karl Storz Endoscopy devices

Submission Details

510(k) Number K982905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1998
Decision Date October 05, 1998
Days to Decision 48 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
82d faster than avg
Panel avg: 130d · This submission: 48d
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 Consultant

KARL STORZ Endoscopy-America, Inc.
Leigh A Spotten

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FGB Ureteroscope And Accessories, Flexible/rigid

All 86
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K982905.
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
URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042
K990050 · Richard Wolf Medical Instruments Corp. · Mar 1999
12 URETEROSCOPES/URETERO-RENOSCOPES
K963855 · Richard Wolf Medical Instruments Corp. · Apr 1997
KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE
K970427 · Karl Storz Endoscopy · Mar 1997
KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE
K960323 · KARL STORZ Endoscopy-America, Inc. · Apr 1996