510(k) K980247
- Device
- GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
- Applicant
- GYNEX CORP.
- 510(k) number
- K980247
- Product code
- HDC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-03-17
- Date received
- 1998-01-23
- Regulation
- 884.4530
- Classification name
- Tenaculum, Uterine
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID W SCHLERF
- Address
- 1000 Burnett Ave., Suite 450 Concord CA US 94520 94520
FDA Registration Numbers#
- 3014334038
- 9611112
- 3005809810
- 9710524
- 3026961173
- 8043404
- 3004215117
- 3011137372
- 9614068
- 3006554912
- 3009988302
- 3010041511
- 1923569
- 8040233
- 9612074
- 3004608878
- 9614062
- 3003418325
- 3012507533
- 8040179
- 8010665
- 3032109
- 3008252486
Source Documents#
Other 510(k) Records For Product Code HDC #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases