Cleared Traditional

K091962 - POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER (FDA 510(k) Clearance)

Also includes:
10,000 PIXEL FIBER OPTIC XENON LIGHT SOURCE, MODEL LS-200

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

K091962 · Lumenis, Inc. · Gastroenterology & Urology device
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Sep 2009
Decision
91d
Days
Class 2
Risk

K091962 is an FDA 510(k) clearance for the POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER. Classified as Mini Endoscope, Gastroenterology-urology (product code ODF), Class II - Special Controls.

Submitted by Lumenis, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 30, 2009 after a review of 91 days - within the typical 510(k) review window.

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 Lumenis, Inc. devices

Submission Details

510(k) Number K091962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date September 30, 2009
Days to Decision 91 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
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODF Mini Endoscope, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures In Body Cavities Of The Gi And Gu Tract. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type 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.