Cleared Traditional

K202237 - Locking device

K202237 is an FDA 510(k) clearance for Locking device, manufactured by Hangzhou AGS MedTech Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code ODC cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K202237 · Hangzhou AGS MedTech Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 2020
Decision
138d
Days
Class 2
Risk

K202237 is an FDA 510(k) clearance for the Locking device. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 23, 2020 after a review of 138 days - within the typical 510(k) review window.

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 Hangzhou AGS MedTech Co., Ltd. devices

FDA 510(k) Submission Details - K202237

510(k) Number K202237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2020
Decision Date December 23, 2020
Days to Decision 138 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
8d slower than avg
Panel avg: 130d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODC Device Classification - Class 2, Special Controls

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 50
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K202237.
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K192048 · Anrei Medical (Hangzhou) Co., Ltd. · May 2020