AQUASENS FLUID MONITORING SYSTEM
FDA 510(k) clearance K031213 · decided 2003-04-30
Clearance details
- K-number
- K031213
- Device name
- AQUASENS FLUID MONITORING SYSTEM
- Applicant
- Davol, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-17
- Decision date
- 2003-04-30
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- HIG
- Device class
- 2
- Regulation number
- 884.1700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Cranston, RI, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Arista AH (P050038/S042) | Davol, Inc. | 2024-11-04 |
| Arista AH (P050038/S040) | Davol, Inc. | 2023-08-09 |
| FlexiTip XL-R Applicator (P050038/S041) | Davol, Inc. | 2023-05-24 |
| Arista AH Absorbable Hemostatic Particles device (P050038/S038) | Davol, Inc. | 2021-10-22 |
| Arista AH Absorbable Hemostatic Particles Device (P050038/S039) | Davol, Inc. | 2021-08-20 |
| Arista AH Absorbable Hemostatic Particles (P050038/S037) | Davol, Inc. | 2021-07-06 |
| Arista AH Absorbable Hemostatic (P050038/S036) | Davol, Inc. | 2020-09-25 |
| Arista AH Absorbable Hemostatic Particles (P050038/S035) | Davol, Inc. | 2020-04-29 |