Cleared Traditional

ClearPetra Suction-Evacuation Sheath (K161110) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161110 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology device
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Oct 2016
Decision
175d
Days
Class 2
Risk

K161110 is an FDA 510(k) clearance for the ClearPetra Suction-Evacuation Sheath. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 12, 2016 after a review of 175 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 Well Lead Medical Co., Ltd. devices

Submission Details

510(k) Number K161110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2016
Decision Date October 12, 2016
Days to Decision 175 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
45d slower than avg
Panel avg: 130d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 49
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K161110.
Trans-anal Introducer
K171208 · Visionsense, Ltd. · Feb 2018
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
K172575 · Baronova, Inc. · Jan 2018
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
K172217 · Cook Incorporated · Dec 2017
Proxis Ureteral Access Sheath
K160861 · C.R. Bard, Inc. · Mar 2016
NAVIGATOR HD URETERAL ACCESS SHEATH SET
K122649 · Boston Scientific Corp · Dec 2012
SPYSCOPE ACCESS AND DELIVERY CATHETER
K051504 · Boston Scientific Corp · Jun 2005