Aquilex Fluid Control System AQL-100S
FDA 510(k) clearance K172040 · decided 2018-02-05
Clearance details
- K-number
- K172040
- Device name
- Aquilex Fluid Control System AQL-100S
- Applicant
- W.O.M. World of Medicine GmbH
- Decision
- Substantially Equivalent
- Date received
- 2017-07-05
- Decision date
- 2018-02-05
- Days to decision
- 215 days
- Clearance type
- Special
- Product code
- HIG
- Device class
- 2
- Regulation number
- 884.1700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Berlin, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during dia recall (Z-2629-2023) | WOM World Of Medicine AG | 2024-01-05 |