HDC — Tenaculum, Uterine Class II

FDA Device Classification

Classification Details

Product Code
HDC
Device Class
Class II
Regulation Number
884.4530
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K223866aspivixCarevix™ Suction Cervical StabilizerJanuary 25, 2023
K203820aspivixASPIVIX v1.1 Cervical Suction TenaculumAugust 17, 2021
K142204bioceptiveBioceptive Suction Cervical RetractorDecember 19, 2014
K082349j. jamner surgical instrumentsJARIT HULKA UTERINE TENACULUM FORCEPSNovember 21, 2008
K073182gyn-disposablesGYN DISPOSABLES TENACULUM 356TNovember 28, 2007
K062563fem suiteFEMTEN CERVICAL TENACULUMMay 18, 2007
K060573vascular control systemsBURBANK TENACULUMApril 21, 2006
K032585ron-tech medicalTRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEMJanuary 9, 2004
K030078vascular control systemsBURBANK TENACULUM, MODEL 09-0011-01January 24, 2003
K001818towne brothers (pvt.)UTERINE TENACLUM HOOKAugust 30, 2000
K992071ron-tech medicalTRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICEAugust 27, 1999
K980247gynexGYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUMMarch 17, 1998
K930037thomasville medical assocATRAUMATIC TENACULAFebruary 24, 1994
K910287marlo surgical technologyOTT CERVICAL TENACULUMFebruary 28, 1991
K894891commercial products and engineeringIRRIGATOR STANDAugust 23, 1989
K891350simpson/basyeNEWPORT CERVICAL MANIPULATORMarch 29, 1989
K891349simpson/basyeCAMPION CERVICAL HOOKMarch 29, 1989
K891347simpson/basyeREID ENDOCERVICAL SPREADERMarch 29, 1989
K891033zinnanti surgical instrumentsATRAUMATIC TENACULAMarch 17, 1989
K890379kinetic medical productsUTERINE TENTACULUMFebruary 13, 1989