Product code FHF
- Device name
- System, Evacuator, Fluid
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4370
- Review panel
- GU
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860009877801 | Clearwand | MORRIS MEDICAL, INC. | 2024-10-22 |
| 03700512901068 | Laparoscopy - 1 Way High Flow Irrigation/Aspiration set + Handpiece & probe (Æ | Promepla | 2016-10-11 |
| 03700512901051 | Laparoscopy - 2 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip) | Promepla | 2016-10-11 |
| 03700512901044 | Laparoscopy - 1 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip) | Promepla | 2016-10-11 |
| 03700512901037 | Laparoscopy - 1 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip, | Promepla | 2016-10-11 |
| 03700512901020 | Laparoscopy - 1 Way Irrigation/Aspiration set (without handpiece & probe) | Promepla | 2016-10-11 |
| 00607915117023 | Suction Irrigation System | APPLIED MEDICAL RESOURCES CORPORATION | 2016-08-18 |
| 00607915117009 | Suction Irrigation System | APPLIED MEDICAL RESOURCES CORPORATION | 2016-08-18 |
| 00607915116989 | Suction Irrigation System | APPLIED MEDICAL RESOURCES CORPORATION | 2016-08-18 |
| 30607915127047 | LAP CHOLE KIT | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-16 |
| 30607915120499 | AM- CHOLE KIT- PORT MAC Q | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-16 |
| 20607915135601 | GENERAL KIT 2 | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915135816 | KIT KE179 COLON | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915135755 | KIT KE183 COLE | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915135724 | KIT KE214 COLE | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915129358 | KIT KE063 COLE | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915135557 | KE038 VES | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915135366 | KIT KE180 COLE SOL 5MM | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915135113 | KIT KE211 COLE 5MM | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915134857 | KIT KE201 COLE | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915133898 | KIT KE226 COLON | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915133287 | CHOLE KIT 23 | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915132501 | KIT KE177 COLE HASSON | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915132044 | CHOLE KIT 15 | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915132037 | CHOLE KIT 11 | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915132006 | K0592 CHOLE KIT | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915131214 | KIT KE093 COLE COMP | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915131191 | KE089 BASICO COLE | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915130774 | KE116 COLE COMPLETO | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915129372 | KIT KE069 COLE DISE | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |