Cleared Traditional

K061622 - PS SERIES

K061622 is an FDA 510(k) clearance for PS SERIES, manufactured by Photonic Optische Gerate Gesmbh & Cokg. The device is a Class 2 Gastroenterology & Urology device with product code FFS cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K061622 · Photonic Optische Gerate Gesmbh & Cokg · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K061622

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 131d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FFS Device Classification - Class 2, Special Controls

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 Consultant

Tuv America, Inc.
STEFAN PREISS

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 - FFS Image, Illumination, Fiberoptic, For Endoscope

All 14
Devices cleared under the same product code (FFS) and FDA review panel - the closest regulatory comparables to K061622.
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
K072521 · Cook Urological, Inc. · Nov 2007
TRU-CABLE
K063309 · Truphatek International, Ltd. · Jan 2007
ACCUTECH ENDOLITE PROBE
K061025 · Accutech Medical Technologies, Inc. · May 2006
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
K994084 · Smith & Nephew, Inc. · Jan 2000
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
K991323 · Smith & Nephew, Inc. · Jul 1999
SOLARTEC SOURCE 270, MODEL # 90123
K983714 · Cogent Light Technologies, Inc. · Dec 1998

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.