Cleared Traditional

K102059 - AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017

K102059 is the FDA 510(k) clearance for AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 by Olympus Medical Systems Corporation. It is a Class 2 Gastroenterology & Urology device (product code FET) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K102059 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
78d
Days
Class 2
Risk

K102059 is an FDA 510(k) clearance for the AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on October 8, 2010 after a review of 78 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 Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K102059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2010
Decision Date October 08, 2010
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 50
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K102059.
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
K130423 · Richard Wolf Medical Instruments Corp. · Apr 2013
PENTAX EPK-I5020 VIDEO PROCESSOR
K113873 · Pentax of America, Inc. · Jun 2012
IMAGE1 GI CCU MODEL 22203020-114
K111997 · KARL STORZ Endoscopy-America, Inc. · Apr 2012
HD CAMERA HEAD OTV-S7PROH-HD-L08E
K083155 · Olympus Medical Systems Corporation · Jan 2009
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
K070716 · KARL STORZ Endoscopy-America, Inc. · May 2007
AIDA WITH DICOM AND HL7 INTERFACE
K043324 · KARL STORZ Endoscopy-America, Inc. · Apr 2005