Product code HDC
- Device name
- Tenaculum, Uterine
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223866 | Carevix™ Suction Cervical Stabilizer | Aspivix SA | 2023-01-25 |
| K203820 | ASPIVIX v1.1 Cervical Suction Tenaculum | Aspivix SA | 2021-08-17 |
| K142204 | Bioceptive Suction Cervical Retractor | Bioceptive, Inc. | 2014-12-19 |
| K082349 | JARIT HULKA UTERINE TENACULUM FORCEPS | J. Jamner Surgical Instruments, Inc. | 2008-11-21 |
| K073182 | GYN DISPOSABLES TENACULUM 356T | Gyn-Disposables, Inc. | 2007-11-28 |
| K062563 | FEMTEN CERVICAL TENACULUM | Fem Suite, LLC | 2007-05-18 |
| K060573 | BURBANK TENACULUM | Vascular Control Systems, Inc. | 2006-04-21 |
| K032585 | TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM | Ron-Tech Medical , Ltd. | 2004-01-09 |
| K030078 | BURBANK TENACULUM, MODEL 09-0011-01 | Vascular Control Systems, Inc. | 2003-01-24 |
| K001818 | UTERINE TENACLUM HOOK | Towne Brothers (Pvt.), Ltd. | 2000-08-30 |
| K992071 | TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE | Ron-Tech Medical , Ltd. | 1999-08-27 |
| K980247 | GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM | Gynex Corp. | 1998-03-17 |
| K930037 | ATRAUMATIC TENACULA | Thomasville Medical Assoc. | 1994-02-24 |
| K910287 | OTT CERVICAL TENACULUM | Marlo Surgical Technology | 1991-02-28 |
| K894891 | IRRIGATOR STAND | Commercial Products & Engineering Co. | 1989-08-23 |
| K891347 | REID ENDOCERVICAL SPREADER | Simpson/Basye, Inc. | 1989-03-29 |
| K891349 | CAMPION CERVICAL HOOK | Simpson/Basye, Inc. | 1989-03-29 |
| K891350 | NEWPORT CERVICAL MANIPULATOR | Simpson/Basye, Inc. | 1989-03-29 |
| K891033 | ATRAUMATIC TENACULA | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| K890379 | UTERINE TENTACULUM | Kinetic Medical Products | 1989-02-13 |
Related GUDID Devices#
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|---|---|---|---|
| 10381780158554 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780159490 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780158608 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780158592 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780158585 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780158578 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780158561 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780158547 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-14 |
| 10381780127611 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127598 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127604 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127628 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127635 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780127581 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780158479 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158530 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158417 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158523 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158516 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158486 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158509 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158615 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158622 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158639 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158646 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158653 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158660 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158677 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158684 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780158493 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |