Cleared Traditional

K062725 - MAXIFLEX-SEMI FLEX SCOPE

K062725 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 16-day FDA review.

K062725 · Technology Delivery Systems, Inc. · Gastroenterology & Urology device
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Sep 2006
Decision
16d
Days
Class 2
Risk

K062725 is an FDA 510(k) clearance for the MAXIFLEX-SEMI FLEX SCOPE. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Technology Delivery Systems, Inc. (Great Neck, US). The FDA issued a Cleared decision on September 29, 2006 after a review of 16 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 Technology Delivery Systems, Inc. devices

FDA 510(k) Submission Details - K062725

510(k) Number K062725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2006
Decision Date September 29, 2006
Days to Decision 16 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 131d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

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 102
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K062725.
STRYKER VIDEO URETEROSCOPE
K121112 · Stryker Endoscopy · Sep 2012
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
K111480 · Technology Delivery Systems, Inc. · Apr 2012
RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
K062707 · Innovative Endoscopy Components, LLC · Dec 2006
ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
K052044 · Acmi Corporation · Aug 2005
STRYKER URETEROSCOPE
K043021 · Stryker Endoscopy · Mar 2005
OLYMPUS VIDEO URETEROSCOPE, NTSC
K033651 · Olympus Winter & Ibe GmbH · Jan 2004

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.