AMSure® Pre-filled Syringe for Balloon Inflation Receives FDA 510(k) Clearance
Pomona, Ca — Amsino Medical Group announces that the new AMSure® pre-filled syringe for balloon inflation with sterile water has received United States Food and Drug Administration (FDA) 510(k) clearance as a Urological Catheter and Accessories, Class II device for indwelling catheter balloon inflation applications. Amsino has expanded its manufacturing capabilities to include the production of sterile saline water products. This new clearance is a first in a series of advancements and sterile water product line extensions at Amsino.
Dr. Richard Lee, Chairman and CEO of Amsino stated “Manufacturing sterile water is a major milestone for Amsino and is a perfect way for us to expand our reach into ancillary products that complement our current product lines and to further expand into saline and adjacent markets.”
The pre-filled syringe for balloon inflation with sterile water is an integral product in the AMSure Urological Care product line. This new product will now be included in Amsino Foley insertion trays and kits. The syringe is pre-filled with USP purified water for quick catheter inflation and gamma irradiated to support infection control practices and patient safety. The syringe is available in 10 cc and 30 cc sizes and the clear polypropylene barrel allows for viewable contents and easy to read volume graduations. This new product is yet another solution for infection prevention included in the reputable AMSure Urological Care line of products.
Adding sterile water to its full range of product manufacturing capabilities is a continuation of Amsino’s long history of providing medical devices that help enhance infection control, improve safety and effectiveness of patient care. Stringent production processes and an enhanced value chain enable Amsino to produce the highest quality sterile water products for its customers. This product is the first, in what will be a long line, of sterile water products offered by Amsino.
Established in the U.S. in 1993, Amsino develops, manufactures and markets medical products that help improve the safety and effectiveness of patient care under a portfolio of globally recognized Amsino brands. We operate several U.S. FDA qualified manufacturing and R&D facilities globally under ISO13485 quality management system.