Product code HES
- Device name
- Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.1300
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140761 | KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA | Carefusion 2200, Inc. | 2014-04-21 |
| K000340 | HYSTALOG HSG CATHETER | Rocket Medical Plc | 2000-04-19 |
| K903209 | MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER | Adler Instrument Co. | 1990-12-21 |
| K903208 | MAXI-FLOW INSUFFLATOR TUBING SET | Adler Instrument Co. | 1990-12-17 |
| K904473 | KRONNER MANIPUJECTOR | Unimar, Inc. | 1990-12-14 |
| K901413 | CORE DISPOSABLE INSUFFLATION TUBING | Core Dynamics, Inc. | 1990-09-24 |
| K891290 | SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER | Cook Ob/Gyn | 1989-05-23 |
| K890869 | BARD HYSTEROSALPINGOGRAPHY CATHETERS | C.R. Bard, Inc. | 1989-04-25 |
| K875137 | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC | F.M. Wiest USA, Inc. | 1988-03-02 |
| K873515 | UTERINE INJECTOR 2MM | Zinnanti Surgical Instruments, Inc. | 1987-09-29 |
| K862310 | CABOT MEDICAL VARIABLE FLOW INSUFFLATOR | Cabot Medical Corp. | 1986-08-12 |
| K844173 | FEMTEST | Bionexus, Inc. | 1985-08-14 |
| K841682 | UTERINE INJECTOR 4.0MM | Humi Corp. | 1984-07-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05055270966148 | Rocket | ROCKET MEDICAL PLC | 2023-10-31 |
| 05055270974440 | Rocket | ROCKET MEDICAL PLC | 2023-10-31 |
| 05055270966155 | Rocket | ROCKET MEDICAL PLC | 2023-10-31 |
| 05055270974457 | Rocket | ROCKET MEDICAL PLC | 2023-10-31 |
| 05055270981370 | Rocket | ROCKET MEDICAL PLC | 2023-10-24 |
| 05055270981387 | Rocket | ROCKET MEDICAL PLC | 2023-10-24 |
| 00887517021472 | PRECICE® Plating System | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. | 2020-01-06 |
| 20888937014765 | Kronner Manipujector | Coopersurgical, Inc. | 2019-01-31 |
| 00888937015805 | Kronner Manipujector | Coopersurgical, Inc. | 2019-01-31 |
| 00827002303683 | Cook | COOK INCORPORATED | 2016-11-04 |
| 10827002248134 | uVue | COOK INCORPORATED | 2016-09-24 |
| 10827002174716 | Cook | COOK INCORPORATED | 2016-09-24 |
| 10827002174723 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002175907 | Cook | COOK INCORPORATED | 2016-09-24 |
| 10827002178707 | Cook | COOK INCORPORATED | 2016-09-24 |
| 20653405045479 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |
| 00827002303973 | Cook | COOK INCORPORATED | 2016-09-24 |
| 30653405074728 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |
| 70885403159956 | V. Mueller | STERIS CORPORATION | 2016-09-24 |
| 10827002171470 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002165755 | Sholkoff | COOK INCORPORATED | 2016-09-24 |
| 10885403045134 | V. Mueller | CAREFUSION 2200, INC | 2016-09-24 |
| 10653405045465 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |
| 10885403050084 | V. Mueller | STERIS CORPORATION | 2016-09-24 |
| 10885403045127 | V. Mueller | STERIS CORPORATION | 2016-09-24 |
| 10885403045110 | V. Mueller | STERIS CORPORATION | 2016-09-24 |
| 10885403045097 | V. Mueller | STERIS CORPORATION | 2016-09-24 |
| 10885403045080 | V. Mueller | STERIS CORPORATION | 2016-09-24 |
| 00827002248137 | uVue | COOK INCORPORATED | 2016-09-24 |
| 10653405045472 | CORE DYNAMICS | Conmed Corporation | 2016-09-24 |