| Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH) DICE@fda.hhs.gov e-mail account.
Dear Sofiane Mah:
Upon searching the releasable 510(k) database http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm, I found the serveral cleared 510(k)s for TransEnterix. However, none were recently (last 6 months) cleared or for the SurgiBot.
I suggest that you contact the manufacturer directly regarding the status of their 510(k).
Submissions that are currently under review, withdrawn, rejected or otherwise not cleared by the agency are not published anywhere because they are confidential. FDA only releases information on submissions that are cleared or approved.
Sincerely,
Crystal R. Thompson
Consumer Safety Officer
Division of Industry and Consumer Education
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify DICE by email at:DICE@fda.hhs.gov immediately.
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