Panels › Obstetrics/Gynecology › Product code HDC · Class 2
Tenaculum, Uterine
Regulation 884.4530
0510(k)s in 12 months (20 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in HDC
| Company | 510(k)s | Recalls |
|---|---|---|
| Stradis Medical, LLC dba Stradis Healthcare | 0 | 6 |
| Simpson/Basye, Inc. | 3 | 0 |
| Aspivix SA | 2 | 0 |
| Gyn-Disposables, Inc. | 1 | 1 |
| Ron-Tech Medical , Ltd. | 2 | 0 |
| Vascular Control Systems, Inc. | 2 | 0 |
| Bioceptive, Inc. | 1 | 0 |
| Commercial Products & Engineering Co. | 1 | 0 |
| Fem Suite, LLC | 1 | 0 |
| Gynex Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 2023 | K223866 | Carevix Suction Cervical Stabilizer Aspivix SA, CH | HDC |
| Aug 17, 2021 | K203820 | ASPIVIX v1.1 Cervical Suction Tenaculum Aspivix SA, CH | HDC |
| Dec 19, 2014 | K142204 | Bioceptive Suction Cervical Retractor Bioceptive, Inc. | HDC |
| Nov 21, 2008 | K082349 | JARIT HULKA UTERINE TENACULUM FORCEPS J. Jamner Surgical Instruments, Inc. | HDC |
| Nov 28, 2007 | K073182 | GYN DISPOSABLES TENACULUM 356T Gyn-Disposables, Inc. | HDC |
| May 18, 2007 | K062563 | FEMTEN CERVICAL TENACULUM Fem Suite, LLC | HDC |
| Apr 21, 2006 | K060573 | BURBANK TENACULUM Vascular Control Systems, Inc. | HDC |
| Jan 9, 2004 | K032585 | TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM Ron-Tech Medical , Ltd., IL | HDC |
| Jan 24, 2003 | K030078 | BURBANK TENACULUM, MODEL 09-0011-01 Vascular Control Systems, Inc. | HDC |
| Aug 30, 2000 | K001818 | UTERINE TENACLUM HOOK Towne Brothers (Pvt.), Ltd., PK | HDC |
| Aug 27, 1999 | K992071 | TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE Ron-Tech Medical , Ltd., IL | HDC |
| Mar 17, 1998 | K980247 | GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM Gynex Corp. | HDC |
| Feb 24, 1994 | K930037 | ATRAUMATIC TENACULA Thomasville Medical Assoc. | HDC |
| Feb 28, 1991 | K910287 | OTT CERVICAL TENACULUM Marlo Surgical Technology | HDC |
| Aug 23, 1989 | K894891 | IRRIGATOR STAND Commercial Products & Engineering Co. | HDC |
| Mar 29, 1989 | K891350 | NEWPORT CERVICAL MANIPULATOR Simpson/Basye, Inc. | HDC |
| Mar 29, 1989 | K891349 | CAMPION CERVICAL HOOK Simpson/Basye, Inc. | HDC |
| Mar 29, 1989 | K891347 | REID ENDOCERVICAL SPREADER Simpson/Basye, Inc. | HDC |
| Mar 17, 1989 | K891033 | ATRAUMATIC TENACULA Zinnanti Surgical Instruments, Inc. | HDC |
| Feb 13, 1989 | K890379 | UTERINE TENTACULUM Kinetic Medical Products | HDC |
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