Carevix™ Suction Cervical Stabilizer
FDA 510(k) clearance K223866 · decided 2023-01-25
Clearance details
- K-number
- K223866
- Device name
- Carevix™ Suction Cervical Stabilizer
- Applicant
- Aspivix SA
- Decision
- Substantially Equivalent
- Date received
- 2022-12-23
- Decision date
- 2023-01-25
- Days to decision
- 33 days
- Clearance type
- Special
- Product code
- HDC
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Renens, CH
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ASPIVIX v1.1 Cervical Suction Tenaculum (K203820) | Aspivix SA | 2021-08-17 |
| Bioceptive Suction Cervical Retractor (K142204) | Bioceptive, Inc. | 2014-12-19 |
| JARIT HULKA UTERINE TENACULUM FORCEPS (K082349) | J. Jamner Surgical Instruments, Inc. | 2008-11-21 |
| GYN DISPOSABLES TENACULUM 356T (K073182) | Gyn-Disposables, Inc. | 2007-11-28 |
| FEMTEN CERVICAL TENACULUM (K062563) | Fem Suite, LLC | 2007-05-18 |
| BURBANK TENACULUM (K060573) | Vascular Control Systems, Inc. | 2006-04-21 |
| TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM (K032585) | Ron-Tech Medical , Ltd. | 2004-01-09 |
| BURBANK TENACULUM, MODEL 09-0011-01 (K030078) | Vascular Control Systems, Inc. | 2003-01-24 |
| UTERINE TENACLUM HOOK (K001818) | Towne Brothers (Pvt.), Ltd. | 2000-08-30 |
| TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE (K992071) | Ron-Tech Medical , Ltd. | 1999-08-27 |
| GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM (K980247) | Gynex Corp. | 1998-03-17 |
| ATRAUMATIC TENACULA (K930037) | Thomasville Medical Assoc. | 1994-02-24 |
Recalls involving this device
No recalls on record reference this clearance.