Cleared Traditional

K111480 - MAXIFLEX - SEMI FLEX SCOPE

K111480 is an FDA 510(k) clearance for MAXIFLEX - SEMI FLEX SCOPE, manufactured by Technology Delivery Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K111480 · Technology Delivery Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
313d
Days
Class 2
Risk

K111480 is an FDA 510(k) clearance for the MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Technology Delivery Systems, Inc. (New Orleans, US). The FDA issued a Cleared decision on April 4, 2012 after a review of 313 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 Technology Delivery Systems, Inc. devices

FDA 510(k) Submission Details - K111480

510(k) Number K111480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2011
Decision Date April 04, 2012
Days to Decision 313 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
183d slower than avg
Panel avg: 130d · This submission: 313d
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 K111480.
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
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K043021 · Stryker Endoscopy · Mar 2005
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K033651 · Olympus Winter & Ibe GmbH · Jan 2004
STRYKER FLEXIBLE URETEROSCOPE
K031278 · Stryker Endoscopy · Oct 2003