Cleared Traditional

K222354 - Elastic Traction System (FDA 510(k) Clearance)

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

K222354 · Micro-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology device
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Oct 2022
Decision
60d
Days
Class 2
Risk

K222354 is an FDA 510(k) clearance for the Elastic Traction System. Classified as Endoscopic Traction Device (product code QSW), Class II - Special Controls.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on October 3, 2022 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4410 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro-Tech (Nanjing) Co., Ltd. devices

Submission Details

510(k) Number K222354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2022
Decision Date October 03, 2022
Days to Decision 60 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
70d faster than avg
Panel avg: 130d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QSW Endoscopic Traction Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4410
Definition An Endoscopic Traction Device Is A Prescription Device That Is Endoscopically Applied To Retract Tissue In The Gastrointestinal Tract During Dissection Procedures To Increase Visualization Of The Dissection Plane And Assist In Tissue Resection, Exposure, And Removal.
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.