Product code HGD
- Device name
- Applicator, Vaginal
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 1
- Regulation number
- 884.4520
- 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 |
|---|---|---|---|
| K823517 | THE KLINE APPLICATOR | Kline Technologies, Ltd. | 1983-01-18 |
Related GUDID Devices#
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|---|---|---|---|
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| 00860012119387 | Reia | Reia, LLC | 2024-07-22 |
| 00860012119370 | Reia | Reia, LLC | 2024-07-22 |
| 00860012119363 | Reia | Reia, LLC | 2024-07-22 |
| 00850016867728 | Pixie Cup | Pixie Cup LLC | 2023-11-20 |
| 00850016867377 | Pixie Cup | Pixie Cup LLC | 2023-11-20 |
| 00719113275860 | Vaginal Applicator | Mai/Genesis | 2023-09-14 |
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| 10338779998417 | Vaginal Suppository Applicator | Medisca Inc. | 2023-09-10 |
| 10338779998431 | Vaginal Suppository Applicator | Medisca Inc. | 2023-09-10 |
| 00338779998434 | Vaginal Suppository Applicator | Medisca Inc. | 2023-09-10 |
| 00338779998427 | Vaginal Suppository Applicator | Medisca Inc. | 2023-09-10 |
| 00338779998410 | Vaginal Suppository Applicator | Medisca Inc. | 2023-09-10 |
| 00860009492905 | VCA Lite | Pce, Inc. | 2023-08-11 |
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| 00653160055733 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160243342 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
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| 10193489342970 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-08-27 |
| 00025715693156 | Ezy Dose | APOTHECARY PRODUCTS, LLC | 2020-10-28 |
| 50885403184480 | NA | CAREFUSION 2200, INC | 2018-07-18 |
| 10885403184482 | NA | CAREFUSION 2200, INC | 2018-07-18 |