510(k) K901428

DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE by Telemed Systems, Inc. — Product Code FDI

K901428 is an FDA 510(k) premarket notification submitted by Telemed Systems, Inc. for the device "DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE". The FDA issued a decision of Substantially Equivalent on June 18, 1990. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Telemed Systems, Inc. has at least 10 other 510(k) clearances on record.