Product code HDQ
- Device name
- Dilator, Cervical, Fixed Size
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 1
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K930034 | CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON | Thomasville Medical Assoc. | 1994-02-24 |
| K896701 | TEFLON CERVICAL ACCESS SET | Cook Ob/Gyn | 1990-09-13 |
| K891029 | CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| K890377 | FIXED-SIZE UTERINE DILATOR | Kinetic Medical Products | 1989-02-13 |
| K811568 | CERVICAL DILATOR | Gynemetrics, Inc. | 1981-07-16 |
| K791277 | MODEL 6500 EXTRACTION IRRIGATION SYS | Cavitron Corp. | 1979-08-22 |
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| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04719894432441 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432458 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432434 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| G586NSGU40600160 | Novo Surgical | NOVO SURGICAL, INC. | 2024-03-08 |
| GYNX42211 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX42551 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX42501 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX42451 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX42401 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX42231 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX42221 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX42131 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX42121 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX42111 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| 08800142924132 | V-Guide | RF Medical Co.,Ltd. | 2023-10-25 |
| 08800142924101 | V-Guide | RF Medical Co.,Ltd. | 2023-10-25 |
| 08800142924071 | V-Guide | RF Medical Co.,Ltd. | 2023-10-25 |
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| 07899798202634 | Schobell | Schobell Industrial Ltda | 2023-01-09 |
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