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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tenaculum, Uterine
510(k) Number K142204
Device Name Bioceptive Suction Cervical Retractor
Applicant
Bioceptive Inc.
New Orleans BioInnovation Center, 1441 Canal Street, Ste 228
New Orleans,  LA  70112
Applicant Contact Steward B. Davis, M.D.
Correspondent
Bioceptive Inc.
New Orleans BioInnovation Center, 1441 Canal Street, Ste 228
New Orleans,  LA  70112
Correspondent Contact Steward B. Davis, M.D.
Regulation Number884.4530
Classification Product Code
HDC  
Date Received08/11/2014
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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