Product Code: HDC FDA class 2 21 CFR 884.4530

Tenaculum, Uterine

Obstetrics/Gynecology

The Uterine Tenaculum is a gynecological surgical instrument with sharp, single- or double-tooth tips used to grasp and stabilize the cervix or uterus during intrauterine procedures such as IUD insertion, hysteroscopy, or endometrial biopsy. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HDC under regulation 21 CFR 884.4530 in the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

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Years Active

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Basic Information

Product Code: HDC
Device Class: FDA class 2
Regulation Number: 884.4530
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K223866	Carevix Suction Cervical Stabilizer	Jan 25, 2023	Substantially Equivalent	Aspivix SA
K203820	ASPIVIX v1.1 Cervical Suction Tenaculum	Aug 17, 2021	Substantially Equivalent	Aspivix SA
K142204	Bioceptive Suction Cervical Retractor	Dec 19, 2014	Substantially Equivalent	Bioceptive, Inc.
K082349	JARIT HULKA UTERINE TENACULUM FORCEPS	Nov 21, 2008	Substantially Equivalent	J. Jamner Surgical Instruments, Inc.
K073182	GYN DISPOSABLES TENACULUM 356T	Nov 28, 2007	Substantially Equivalent	Gyn-Disposables, Inc.
K062563	FEMTEN CERVICAL TENACULUM	May 18, 2007	Substantially Equivalent	Fem Suite, LLC
K060573	BURBANK TENACULUM	Apr 21, 2006	Substantially Equivalent	Vascular Control Systems, Inc.
K032585	TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM	Jan 09, 2004	Substantially Equivalent	Ron-Tech Medical , Ltd.
K030078	BURBANK TENACULUM, MODEL 09-0011-01	Jan 24, 2003	Substantially Equivalent	Vascular Control Systems, Inc.
K001818	UTERINE TENACLUM HOOK	Aug 30, 2000	Substantially Equivalent	Towne Brothers (Pvt.), Ltd.
K992071	TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE	Aug 27, 1999	Substantially Equivalent	Ron-Tech Medical , Ltd.
K980247	GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM	Mar 17, 1998	Substantially Equivalent	Gynex Corp.
K930037	ATRAUMATIC TENACULA	Feb 24, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K910287	OTT CERVICAL TENACULUM	Feb 28, 1991	Substantially Equivalent	Marlo Surgical Technology
K894891	IRRIGATOR STAND	Aug 23, 1989	Substantially Equivalent	Commercial Products & Engineering Co.
K891350	NEWPORT CERVICAL MANIPULATOR	Mar 29, 1989	Substantially Equivalent	Simpson/Basye, Inc.
K891349	CAMPION CERVICAL HOOK	Mar 29, 1989	Substantially Equivalent	Simpson/Basye, Inc.
K891347	REID ENDOCERVICAL SPREADER	Mar 29, 1989	Substantially Equivalent	Simpson/Basye, Inc.
K891033	ATRAUMATIC TENACULA	Mar 17, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K890379	UTERINE TENTACULUM	Feb 13, 1989	Substantially Equivalent	Kinetic Medical Products