K222354 is an FDA 510(k) clearance for the Elastic Traction System. This device is classified as a Endoscopic Traction Device (Class II - Special Controls, product code QSW).
Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on October 3, 2022, 60 days after receiving the submission on August 4, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4410. 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..
| 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 |
| Product Code | QSW — Endoscopic Traction Device |
| Device Class | Class II - 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. |