HDC · Class II · 21 CFR 884.4530

FDA Product Code HDC: Tenaculum, Uterine

Leading manufacturers include Vascular Control Systems, Inc., Aspivix SA and Marlo Surgical Technology.

20
Total
20
Cleared
87d
Avg days
1989
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Tenaculum, Uterine Devices (Product Code HDC)

20 devices
1–20 of 20
Cleared Jan 25, 2023
Carevix™ Suction Cervical Stabilizer
K223866
Aspivix SA
Obstetrics & Gynecology · 33d
Cleared Aug 17, 2021
ASPIVIX v1.1 Cervical Suction Tenaculum
K203820
Aspivix SA
Obstetrics & Gynecology · 231d
Cleared Dec 19, 2014
Bioceptive Suction Cervical Retractor
K142204
Bioceptive, Inc.
Obstetrics & Gynecology · 130d
Cleared Nov 21, 2008
JARIT HULKA UTERINE TENACULUM FORCEPS
K082349
J. Jamner Surgical Instruments, Inc.
Obstetrics & Gynecology · 98d
Cleared Nov 28, 2007
GYN DISPOSABLES TENACULUM 356T
K073182
Gyn-Disposables, Inc.
Obstetrics & Gynecology · 15d
Cleared May 18, 2007
FEMTEN CERVICAL TENACULUM
K062563
Fem Suite, LLC
Obstetrics & Gynecology · 260d
Cleared Apr 21, 2006
BURBANK TENACULUM
K060573
Vascular Control Systems, Inc.
Obstetrics & Gynecology · 46d
Cleared Jan 24, 2003
BURBANK TENACULUM, MODEL 09-0011-01
K030078
Vascular Control Systems, Inc.
Obstetrics & Gynecology · 15d
Cleared Aug 30, 2000
UTERINE TENACLUM HOOK
K001818
Towne Brothers (Pvt.), Ltd.
Obstetrics & Gynecology · 76d
Cleared Aug 27, 1999
TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE
K992071
Ron-Tech Medical , Ltd.
Obstetrics & Gynecology · 70d
Cleared Mar 17, 1998
GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
K980247
Gynex Corp.
Obstetrics & Gynecology · 53d
Cleared Feb 24, 1994
ATRAUMATIC TENACULA
K930037
Thomasville Medical Assoc.
Obstetrics & Gynecology · 415d
Cleared Feb 28, 1991
OTT CERVICAL TENACULUM
K910287
Marlo Surgical Technology
Obstetrics & Gynecology · 37d
Cleared Mar 17, 1989
ATRAUMATIC TENACULA
K891033
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 17d
Cleared Feb 13, 1989
UTERINE TENTACULUM
K890379
Kinetic Medical Products
Obstetrics & Gynecology · 21d

About Product Code HDC - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code HDC since 1989, with 20 receiving FDA clearance (average review time: 87 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.