Cleared Traditional

K102616 - NAVIAID BALLOON GUIDED COLONOSCOPY (BGC...

K102616 is an FDA 510(k) clearance for NAVIAID BALLOON GUIDED COLONOSCOPY (BGC..., 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 111-day FDA review.

K102616 · Smart Medical Systems , Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 2010
Decision
111d
Days
Class 2
Risk

K102616 is an FDA 510(k) clearance for the NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) 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 December 30, 2010 after a review of 111 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 - K102616

510(k) Number K102616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2010
Decision Date December 30, 2010
Days to Decision 111 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
19d faster than avg
Panel avg: 130d · This submission: 111d
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
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