Dilator, Cervical, Fixed Size
FDA product code HDQ · Class I (low risk) · 21 CFR 884.4530 · Obstetrics/Gynecology
6510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930034 | Cervical Dilators:Pratt,Hawkin,Kleegman,DennistonHDQ · Traditional | Thomasville Medical Assoc. | 02/24/1994SE |
| K896701 | Teflon Cervical Access SetHDQ · Traditional | Cook Ob/Gyn | 09/13/1990SE |
| K891029 | Cervical Dilators Pratt,Hawkin,Kleegman,Denn.,VallHDQ · Traditional | Zinnanti Surgical Instruments, Inc. | 03/17/1989SE |
| K890377 | Fixed-Size Uterine DilatorHDQ · Traditional | Kinetic Medical Products | 02/13/1989SE |
| K811568 | Cervical DilatorHDQ · Traditional | Gynemetrics, Inc. | 07/16/1981SE |
| K791277 | Model 6500 Extraction Irrigation SysHDQ · Traditional | Cavitron Corp. | 08/22/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0946-2025 Class II | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-1450-2024 Class II | Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |
| Z-1208-2010 | VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100, VNVD Veronikis…Marina Medical, Sunrise, FL initiated recall of 46 products of 350 series devices and 47 products of 270… | Marina Medical Instruments Inc. | 04/09/2009Terminated |
| Z-1207-2010 | VVD Veronikis Vaginal Dilator - Complete Set Catalog No. 270-000. Set Includes: VVD…Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series… | Marina Medical Instruments Inc. | 04/09/2009Terminated |