Product code HHM
- Device name
- Sound, Uterine
- 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 |
|---|---|---|---|
| K011840 | CERVILENZ UTERINE MEASURING SOUND | Cervilenz, Inc. | 2001-08-10 |
| K935665 | INTRAUTERINE SOUND | Rocket of London, Ltd. | 1994-02-24 |
| K884684 | ROCKET INTRAUTERINE DEPTH SOUND | A & A Medical, Inc. | 1988-12-20 |
| K883806 | ROCKET INTRAUTERINE SOUND | A & A Medical, Inc. | 1988-10-31 |
| K870550 | TEFLON UTERINE SOUND | Cook Ob/Gyn | 1987-03-04 |
| K840380 | UTERINE SOUND | Intl. Medical Technologies, Inc. | 1984-04-30 |
| K831224 | AUGROS HYSTEROMETER | Axcan Scientific Corp. | 1983-10-28 |
| K802315 | UTERINE SOUND | Gynemetrics, Inc. | 1981-01-12 |
| K781766 | UTERINE SOUND, BURNETT DISPOSABLE | C.R. Bard, Inc. | 1978-12-07 |
| K760170 | INTRAUTERINE SOUND, PLASTIC DISPOSABLE | G.D. Searle and Co. | 1976-07-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00190776419356 | Millennium | Avalign Technologies, Inc. | 2026-04-14 |
| 00190776419295 | Millennium | Avalign Technologies, Inc. | 2026-04-14 |
| 00190776408442 | Millennium | Avalign Technologies, Inc. | 2026-04-14 |
| 00190776419301 | Millennium | Avalign Technologies, Inc. | 2026-04-14 |
| 00190776419318 | Millennium | Avalign Technologies, Inc. | 2026-04-14 |
| 00190776419325 | Millennium | Avalign Technologies, Inc. | 2026-04-14 |
| 00190776419332 | Millennium | Avalign Technologies, Inc. | 2026-04-14 |
| 00190776419363 | Millennium | Avalign Technologies, Inc. | 2026-04-14 |
| 00190776419370 | Millennium | Avalign Technologies, Inc. | 2026-04-14 |
| 00190776413361 | Millennium | Avalign Technologies, Inc. | 2025-10-09 |
| 00841742149127 | HNM MEDICAL | HNM STAINLESS, LLC. | 2024-08-30 |
| 04719894432847 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| GYNX49501 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX46751 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX46301 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| GYNX46011 | Gynex | GYNEX CORPORATION | 2023-12-19 |
| 00840343713867 | GEN2 | SURGIX MEDICAL LLC | 2023-01-09 |
| 07898506815173 | Quinelato | Schobell Industrial Ltda | 2023-01-09 |
| 20612479227365 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-15 |
| 10381780509233 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-10-23 |
| 10381780509226 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-10-23 |
| 10381780463979 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-22 |
| 10381780463962 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-22 |
| 10381780441618 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-02-28 |
| 10381780441595 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-02-28 |
| 10381780442561 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-02-05 |
| 10381780435969 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-24 |
| 10381780409434 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780409427 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 00852073002401 | NA | C R I | 2016-10-11 |