Elastic Traction System
FDA 510(k) K222354 · Micro-Tech (Nanjing) Co., Ltd.
510(k) numberK222354
Submission
- Device name
- Elastic Traction System
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
Nanjing, CN - Received
- August 4, 2022
- Decision date
- October 3, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QSW – Endoscopic Traction Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4410
- Specialty
- Gastroenterology, Urology
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.
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Questions and answers
When was Elastic Traction System cleared by the FDA?
Elastic Traction System (K222354) received a 510(k) decision of Substantially Equivalent on October 3, 2022, 60 days after the submission was received.
What is the product code of K222354?
The FDA product code is QSW – Endoscopic Traction Device, a Class II (moderate risk) device regulated under 21 CFR 876.4410.