Cleared Traditional

K082995 - SMART DILATOR

K082995 is an FDA 510(k) clearance for SMART DILATOR, manufactured by Safestitch Medical. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K082995 · Safestitch Medical · Gastroenterology & Urology device
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Feb 2009
Decision
121d
Days
Class 2
Risk

K082995 is an FDA 510(k) clearance for the SMART DILATOR. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Safestitch Medical (Miami, US). The FDA issued a Cleared decision on February 6, 2009 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - 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 Safestitch Medical devices

FDA 510(k) Submission Details - K082995

510(k) Number K082995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2008
Decision Date February 06, 2009
Days to Decision 121 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
9d faster than avg
Panel avg: 130d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNQ Device Classification - Class 2, Special Controls

Product Code KNQ Dilator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
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 - KNQ Dilator, Esophageal

All 22
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K082995.
CRE FIXED WIRE BALLON DILATION CATHETER
K122924 · Boston Scientific Corp · Oct 2012
ETHICON ENDO-SURGERYOPTICAL DILATOR
K093236 · Ethicon Endo-Surgery, Inc. · Nov 2009
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · Boston Scientific Corp · Sep 2006
BARD ELIMINATOR PET BALLOON DILATORS
K033936 · C.R. Bard, Inc. · Jan 2004
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
K031147 · Ethicon Endo-Surgery, Inc. · Jan 2004
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
K023907 · Cordis Corp. · Dec 2002