Cleared Special

ClearPetra Suction-Evacuation Sheath (K203119) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K203119 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology device
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Dec 2020
Decision
54d
Days
Class 2
Risk

K203119 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 December 9, 2020 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Well Lead Medical Co., Ltd. devices

Submission Details

510(k) Number K203119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2020
Decision Date December 09, 2020
Days to Decision 54 days
Submission Type Special
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
76d faster than avg
Panel avg: 130d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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 48
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K203119.
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