Cleared Traditional

HMT ALEXCOPE (K941013) - FDA 510(k) Clearance

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

K941013 · Servicetrends, Inc. · Gastroenterology & Urology device
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Feb 1995
Decision
343d
Days
Class 2
Risk

K941013 is an FDA 510(k) clearance for the HMT ALEXCOPE. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Servicetrends, Inc. (Kennesaw, US). The FDA issued a Cleared decision on February 9, 1995 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Servicetrends, Inc. devices

Submission Details

510(k) Number K941013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1994
Decision Date February 09, 1995
Days to Decision 343 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 130d · This submission: 343d
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 K941013.
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
KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE
K960323 · KARL STORZ Endoscopy-America, Inc. · Apr 1996
KARL STORZ URETERO-RENOSCOPE/URETERSCOPE
K940464 · KARL STORZ Endoscopy-America, Inc. · Jun 1994
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