Cleared Traditional

K101053 - OLYMPUS CF TYPE Y0023-L, Y0023I

K101053 is an FDA 510(k) clearance for OLYMPUS CF TYPE Y0023-L, manufactured by Olympus Medical Systems Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K101053 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
90d
Days
Class 2
Risk

K101053 is an FDA 510(k) clearance for the OLYMPUS CF TYPE Y0023-L, Y0023I. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on July 14, 2010 after a review of 90 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.

FDA 510(k) Submission Details - K101053

510(k) Number K101053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2010
Decision Date July 14, 2010
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDF Device Classification - Class 2, Special Controls

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum 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 Peers - FDF Colonoscope And Accessories, Flexible/rigid

All 113
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K101053.
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
K102616 · Smart Medical Systems , Ltd. · Dec 2010
COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
K100966 · Sheathing Technologies, Inc. · Aug 2010
NAVIAID ICVI DEVICE
K101191 · Smart Medical Systems , Ltd. · Jul 2010
PENTEX EC-3890LI
K093037 · Pentax Medical Company · Dec 2009
MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
K093187 · Avantis Medical Systems, Inc. · Nov 2009
CLEARPATH
K091305 · Easyglide , Ltd. · Oct 2009
K101053 · OLYMPUS CF TYPE Y0023-L, Y0023I
Download PDF FDA Summary Olympus Medical Syste…