510(k) K222354
K222354 is an FDA 510(k) premarket notification submitted by Micro-Tech (Nanjing) Co., Ltd. for the device "Elastic Traction System". The FDA issued a decision of Substantially Equivalent on October 3, 2022. The device falls under product code QSW (Endoscopic Traction Device), a Class II device regulated under 21 CFR 876.4410. Micro-Tech (Nanjing) Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2022
- Date Received
- August 4, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Traction Device
- Device Class
- Class II
- Regulation Number
- 876.4410
- Review Panel
- GU
- Submission Type
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.