Cleared Traditional

K172775 - MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle

K172775 is an FDA 510(k) clearance for MiniLap System with MiniGrip Handle, manufactured by Teleflexmedical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K172775 · Teleflexmedical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2018
Decision
151d
Days
Class 2
Risk

K172775 is an FDA 510(k) clearance for the MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on February 12, 2018 after a review of 151 days - an extended review cycle.

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 Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K172775

510(k) Number K172775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2017
Decision Date February 12, 2018
Days to Decision 151 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
20d slower than avg
Panel avg: 131d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCW Device Classification - Class 2, Special Controls

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
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 - OCW Endoscopic Tissue Approximation Device

All 50
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K172775.
AbClose - Port Site Closure Device
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OverStitch 2-0 Polypropylene Suture
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OverStitch Endoscopic Suturing System and Accessories
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CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor
K172666 · Sutureease, Inc. · Dec 2017
OverStitch SX Endoscopic Suturing System (ESS)
K171886 · Apollo Endosurgery, Inc. · Nov 2017
AbClose - Port Site Closure Device
K160117 · Medeon Biodesign, Inc. · Sep 2016