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510(k) K203820

Device
ASPIVIX v1.1 Cervical Suction Tenaculum
Applicant
Aspivix SA
510(k) number
K203820
Product code
HDC
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-17
Date received
2020-12-29
Regulation
884.4530
Classification name
Tenaculum, Uterine
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Benjamin Klein
Address
Chemin Du Closel Renens CH 1020 1020

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HDC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223866Carevix™ Suction Cervical StabilizerAspivix SA2023-01-25
K142204Bioceptive Suction Cervical RetractorBioceptive, Inc.2014-12-19
K082349JARIT HULKA UTERINE TENACULUM FORCEPSJ. Jamner Surgical Instruments, Inc.2008-11-21
K073182GYN DISPOSABLES TENACULUM 356TGyn-Disposables, Inc.2007-11-28
K062563FEMTEN CERVICAL TENACULUMFem Suite, LLC2007-05-18
K060573BURBANK TENACULUMVascular Control Systems, Inc.2006-04-21
K032585TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEMRon-Tech Medical , Ltd.2004-01-09
K030078BURBANK TENACULUM, MODEL 09-0011-01Vascular Control Systems, Inc.2003-01-24
K001818UTERINE TENACLUM HOOKTowne Brothers (Pvt.), Ltd.2000-08-30
K992071TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICERon-Tech Medical , Ltd.1999-08-27
K980247GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUMGynex Corp.1998-03-17
K930037ATRAUMATIC TENACULAThomasville Medical Assoc.1994-02-24
K910287OTT CERVICAL TENACULUMMarlo Surgical Technology1991-02-28
K894891IRRIGATOR STANDCommercial Products & Engineering Co.1989-08-23
K891347REID ENDOCERVICAL SPREADERSimpson/Basye, Inc.1989-03-29