Alliance Medical Receives 510(k) Clearance from FDA for Ultrasonic Scalpel.PHOENIX -- Alliance Medical Corporation (Alliance), a leading reprocessor of single-use medical devices (SUDs), today announced U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) clearance of Alliance's Reprocessed Ultrasonic Scalpels (510(k) # 043358). The scalpel utilizes ultrasonic energy to enable the cutting and coagulating of soft tissue. "Alliance works closely with the FDA to ensure we meet all regulatory requirements in order to provide our customers with safe and cost effective reprocessed devices," said Liz Stoneman, RN, vice president of Client Services for Alliance Medical. "This clearance is the latest example of Alliance's commitment to providing hospitals a wide variety of devices to support their supply-cost reduction needs through reprocessing Reprocessing may refer to:
The ultrasonic scalpels are used for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery electrosurgery /elec·tro·sur·gery/ (-ser´jer-e) surgery performed by electrical methods; the active electrode may be a needle, bulb, or disk.electrosur´gical e·lec·tro·sur·ger·y n. , lasers and steel scalpels in general, abdominal, pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. , gynecologic gynecologic /gy·ne·co·log·ic/ (gi?ne-) (jin?e-kah-loj´ik) pertaining to the female reproductive tract or to gynecology. and other open and endoscopic procedures. Models in which substantial equivalence was sought have curved, straight and blunt tipped ends and are 5 mm in diameter. Reprocessed ultrasonic scalpels have the same intended use as the original device and do not incorporate new technology, materials or design changes. Having safely reprocessed more than 12 million SUDs, Alliance is one of the industry's most trusted device reprocessing companies, providing hands-on support for customers. Alliance employs clinically trained and experienced service technicians and account executives who utilize its clinically focused, three-phased client support program: Assessment, Implementation and Management (AIM), to set up and manage the most efficient and effective SUD SUD 1. Substance use disorder 2. Sudden unexpected or unexplained death. See Sudden unexplained nocturnal death. reprocessing program. The savings health care facilities achieve as a result can be used for vital patient services, new medical technology and nursing salaries, all of which lead to improved patient care. About Alliance Medical Alliance Medical Corporation is a leading reprocessor of specific single-use medical devices (SUDs) and has safely reprocessed more than 12 million SUDs, saving hospitals and surgery centers in excess of $150 million. Alliance goes beyond providing technically superior medical device reprocessing services to deliver guaranteed maximum supply-cost savings to leading health care organizations. Alliance is differentiated by our unwavering partnership commitment, clinical implementation expertise and dedicated field associates which together ensure that we exceed our partner's goals and expectations. The Company's services focus on reducing supply costs of hospitals and surgery centers suffering from shrinking reimbursements and increasing costs. Alliance has agreements with leading national group purchasing organizations, alliances and supply chain service firms, including VHA VHA Veterans Health Administration VHA Variable Housing Allowance VHA Villages Homeowners Association VHA Voluntary Hospitals Association VHA Virtual Home Agent VHA Very High Altitude VHA Vapor Hazard Area VHA Vermont Holstein-Friesian Association , HealthTrust Purchasing Group (HPG HPG human pituitary gonadotropin. ), Broadlane and University HealthSystem Consortium (UHC UHC UnitedHealthcare UHC United Health Care UHC University Hospitals of Cleveland UHC United Hitech Corporation UHC Udvar-Hazy Center (National Air and Space Museum) UHC University Health/System Consortium UHC Unburned Hydrocarbons ), as well as a number of nationally recognized hospital integrated delivery networks, including Banner Health and Henry Ford Health System that collectively represent more than 4,000 health care facilities. For more information about Alliance Medical Corporation, visit www.alliance-medical.com; or call 888.888.3433. |
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