Cleared Traditional

K140441 - BI-FLEX URETERAL ACCESS SHEATH

K140441 is an FDA 510(k) clearance for BI-FLEX URETERAL ACCESS SHEATH, manufactured by Promepla Sam. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K140441 · Promepla Sam · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
116d
Days
Class 2
Risk

K140441 is an FDA 510(k) clearance for the BI-FLEX URETERAL ACCESS SHEATH. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Promepla Sam (Monaco, MC). The FDA issued a Cleared decision on June 17, 2014 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Promepla Sam devices

FDA 510(k) Submission Details - K140441

510(k) Number K140441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2014
Decision Date June 17, 2014
Days to Decision 116 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
14d faster than avg
Panel avg: 130d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KNY Accessories, Catheter, G-u

All 24
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K140441.
Bi-Flex Evo
K182144 · Promepla Sam · Sep 2018
PBN DRAINAGE CATHETER GUIDEWIRES
K991097 · Medical Device Technologies, Inc. · Apr 1999
HYDROPHILIC COATED GUIDEWIRE
K981667 · Lake Region Mfg., Inc. · Jun 1998
MANAN MANTA CATHETER FIXATION DISK
K981229 · Medical Device Technologies, Inc. · Apr 1998
INSULATOR WIRE GUIDE
K972977 · Cook Urological, Inc. · Oct 1997
LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.
K960866 · Lake Region Mfg., Inc. · Apr 1996