FDA 510(k) Applications for Medical Device Product Code "HDC"
(Tenaculum, Uterine)

FDA 510(k) Number Applicant Device Name Decision Date
K203820 Aspivix S.A. ASPIVIX v1.1 Cervical Suction Tenaculum 08/17/2021
K223866 Aspivix SA CarevixÖ Suction Cervical Stabilizer 01/25/2023
K142204 Bioceptive Inc. Bioceptive Suction Cervical Retractor 12/19/2014
K062563 FEM SUITE, L.L.C. FEMTEN CERVICAL TENACULUM 05/18/2007
K073182 GYN-DISPOSABLES, INC. GYN DISPOSABLES TENACULUM 356T 11/28/2007
K980247 GYNEX CORP. GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM 03/17/1998
K082349 J. JAMNER SURGICAL INSTRUMENTS, INC. JARIT HULKA UTERINE TENACULUM FORCEPS 11/21/2008
K992071 RON-TECH MEDICAL LTD. TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE 08/27/1999
K032585 RON-TECH MEDICAL LTD. TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM 01/09/2004
K001818 TOWNE BROTHERS (PVT.), LTD. UTERINE TENACLUM HOOK 08/30/2000
K060573 VASCULAR CONTROL SYSTEMS, INC BURBANK TENACULUM 04/21/2006
K030078 VASCULAR CONTROL SYSTEMS, INC BURBANK TENACULUM, MODEL 09-0011-01 01/24/2003


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