Limaca Medical Receives FDA 510(k) Clearance for its Breakthrough Precision GI™ Endoscopic Biopsy Device
YOKNEAM, Israel, Sept. 11, 2023 /PRNewswire/ -- Limaca Medical ("Limaca") announced today that its Precision GI™ Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the U.S. Food and Drug Administration ("FDA").
- YOKNEAM, Israel, Sept. 11, 2023 /PRNewswire/ -- Limaca Medical ("Limaca") announced today that its Precision GI™ Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the U.S. Food and Drug Administration ("FDA").
- This follows Limaca's receipt of FDA Breakthrough Device Designation for its Precision GI™.
- FDA clearance allows us to bring Precision GI™ to market to fulfill our mission to always achieve precise, efficient, and definitive biopsy samples."
- Carl Rickenbaugh, Limaca Vice Chair, added, "We are pleased with FDA's clearance of Precision GI™, following our FDA Breakthrough Device Designation.