510(k) K220790

Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Product Code FDI

K220790 is an FDA 510(k) premarket notification submitted by Yangzhou Fartley Medical Instrument Technology Co., Ltd. for the device "Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare". The FDA issued a decision of Substantially Equivalent on June 27, 2022. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Yangzhou Fartley Medical Instrument Technology Co., Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2022
Date Received
March 17, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type