March 2012 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2012
DEVICE: OASYS SURGICAL LIGHT CONTROLLER
OASYS HEALTHCARE 510(k) NO: K112133(TRADITIONAL)
ATTN: TANYA M O'BRIEN PHONE NO : 813 645 2855
962 ALLEGRO LANE SE DECISION MADE: 01-MAR-12
APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FD TENS 2070
FUJI DYNAMICS LTD 510(k) NO: K111654(TRADITIONAL)
The nod means the cobalt-chromium stent is "available in all of the major markets worldwide," according to a press releaase, including the U.S., Europe, China and India.
The FDA lacks consistency in review times for medical device pre-market approval applications, missing most goals for submissions marked "expedited," according to report by the Government Accountability Office.
"For FYs 2003 through 2010, FDA met most of the goals for original PMAs but fell short on most of the goals for expedited PMAs," according to the GAO report. "In addition, FDA review time and time to final decision for both types of PMAs generally increased during this period."
The Mansfield, Mass.-based med-tech titan is preparing a limited market release in the U.S. next month, allowing select hospitals to use the Nellcor system, according to a press release.
Steris Corp. (NYSE:STE) landed special 510(k) clearance to modify its System 1E sterilizers, the replacement systems for the troubled System 1 devices that were the center of a 2-year row with the FDA.
The Mentor, Ohio-based device maker won the FDA’s approval to update existing SS1E devices in the field with modified software, which will also be applied to all new shipments, effective immediately.