Cleared Traditional

K101191 - NAVIAID ICVI DEVICE

K101191 is an FDA 510(k) clearance for NAVIAID ICVI DEVICE, manufactured by Smart Medical Systems , Ltd.. 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.

K101191 · Smart Medical Systems , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
90d
Days
Class 2
Risk

K101191 is an FDA 510(k) clearance for the NAVIAID ICVI DEVICE. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Smart Medical Systems , Ltd. (Raanana, IL). The FDA issued a Cleared decision on July 27, 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.

View all Smart Medical Systems , Ltd. devices

FDA 510(k) Submission Details - K101191

510(k) Number K101191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2010
Decision Date July 27, 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
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · 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 73
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K101191.
EVIS EXERA III VIDEO SYSTEM
K112680 · Olympus Medical Systems Corporation · Feb 2012
EUS BALLOON
K111028 · United States Endoscopy Group, Inc. · Nov 2011
UPD-Y0003
K103312 · Olympus Medical Systems Corporation · May 2011
OLYMPUS CF TYPE Y0023-L, Y0023I
K101053 · Olympus Medical Systems Corporation · Jul 2010
FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
K090116 · Fujinon, Inc. · Apr 2009
KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
K063585 · KARL STORZ Endoscopy-America, Inc. · Jan 2007