FDA Product Code
FDA Product Code HDC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4530
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223866 | Carevix Suction Cervical Stabilizer | Aspivix SA | 2023-01-25 | Special | PDF ↗ |
| K203820 | ASPIVIX v1.1 Cervical Suction Tenaculum | Aspivix SA | 2021-08-17 | Traditional | PDF ↗ |
| K142204 | Bioceptive Suction Cervical Retractor | Bioceptive, Inc. | 2014-12-19 | Traditional | PDF ↗ |
| K082349 | JARIT HULKA UTERINE TENACULUM FORCEPS | J. Jamner Surgical Instruments, Inc. | 2008-11-21 | Traditional | PDF ↗ |
| K073182 | GYN DISPOSABLES TENACULUM 356T | Gyn-Disposables, Inc. | 2007-11-28 | Traditional | PDF ↗ |
| K062563 | FEMTEN CERVICAL TENACULUM | Fem Suite, LLC | 2007-05-18 | Traditional | PDF ↗ |
| K060573 | BURBANK TENACULUM | Vascular Control Systems, Inc. | 2006-04-21 | Traditional | PDF ↗ |
| K032585 | TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM | Ron-Tech Medical , Ltd. | 2004-01-09 | Special | PDF ↗ |
| K030078 | BURBANK TENACULUM, MODEL 09-0011-01 | Vascular Control Systems, Inc. | 2003-01-24 | Traditional | PDF ↗ |
| K001818 | UTERINE TENACLUM HOOK | Towne Brothers (Pvt.), Ltd. | 2000-08-30 | Traditional | PDF ↗ |
| K992071 | TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE | Ron-Tech Medical , Ltd. | 1999-08-27 | Traditional | PDF ↗ |
| K980247 | GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM | Gynex Corp. | 1998-03-17 | Traditional | PDF ↗ |
| K930037 | ATRAUMATIC TENACULA | Thomasville Medical Assoc. | 1994-02-24 | Traditional | PDF ↗ |
| K910287 | OTT CERVICAL TENACULUM | Marlo Surgical Technology | 1991-02-28 | Traditional | PDF ↗ |
| K894891 | IRRIGATOR STAND | Commercial Products & Engineering Co. | 1989-08-23 | Traditional | PDF ↗ |
| K891349 | CAMPION CERVICAL HOOK | Simpson/Basye, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K891350 | NEWPORT CERVICAL MANIPULATOR | Simpson/Basye, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K891347 | REID ENDOCERVICAL SPREADER | Simpson/Basye, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K891033 | ATRAUMATIC TENACULA | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K890379 | UTERINE TENTACULUM | Kinetic Medical Products | 1989-02-13 | Traditional | PDF ↗ |
Product code HDC · Class II · Obstetrics/Gynecology. Data: openFDA.