510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HDCClass II

Tenaculum, Uterine

21 CFR 884.4530 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HDC is the FDA product code for Tenaculum, Uterine, a class II device type, regulated under 21 CFR 884.4530. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
HDC
Device name
Tenaculum, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
20
Ingested recalls
8

Clearances, product code HDC

By decision year
20 clearances under product code HDC with a decision year between 1989 and 2023, 1989 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code HDC by decision year
YearClearances
19896
19911
19941
19981
19991
20001
20031
20041
20061
20072
20081
20141
20211
20231

Applicants with the most clearances

Product code HDC
Applicants holding the most 510(k) clearances under product code HDC
ApplicantClearances
Simpson/Basye, Inc.3
Aspivix SA2
Ron-Tech Medical, Ltd.2
Vascular Control Systems, Inc.2
Bioceptive, Inc.1
Commercial Products & Engineering Co.1
Fem Suite, LLC1
Gyn-Disposables, Inc.1
Gynex Corp.1
J. Jamner Surgical Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order