HDC · Class II · 21 CFR 884.4530

FDA Product Code HDC: Tenaculum, Uterine

Leading manufacturers include Aspivix SA, Kinetic Medical Products and Zinnanti Surgical Instruments, Inc..

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 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.