Cleared Traditional

PS SERIES (K061622) - FDA 510(k) Clearance

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

K061622 · Photonic Optische Gerate Gesmbh & Cokg · Gastroenterology & Urology device
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Mar 2007
Decision
266d
Days
Class 2
Risk

K061622 is an FDA 510(k) clearance for the PS SERIES. Classified as Image, Illumination, Fiberoptic, For Endoscope (product code FFS), Class II - Special Controls.

Submitted by Photonic Optische Gerate Gesmbh & Cokg (Vienna, AT). The FDA issued a Cleared decision on March 5, 2007 after a review of 266 days - an extended review 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: 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 Photonic Optische Gerate Gesmbh & Cokg devices

Submission Details

510(k) Number K061622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2006
Decision Date March 05, 2007
Days to Decision 266 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 130d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code FFS Image, Illumination, Fiberoptic, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - FFS Image, Illumination, Fiberoptic, For Endoscope

All 25
Devices cleared under the same product code (FFS) and FDA review panel - the closest regulatory comparables to K061622.
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K991323 · Smith & Nephew, Inc. · Jul 1999
KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS
K962595 · KARL STORZ Endoscopy-America, Inc. · Sep 1996
KARL STORZ ENDOSCOPY-AMERICA, INC.
K933216 · KARL STORZ Endoscopy-America, Inc. · Sep 1993