Aquilex Fluid Control System AQL-100S— 510(k) K172040
Substantially EquivalentW.O.M. World of Medicine GmbH
FDA 510(k) clearance K172040 for Aquilex Fluid Control System AQL-100S, Substantially Equivalent on 2018-02-05. Applicant: W.O.M. World of Medicine GmbH. Device class: 2.
Clearance details
- Applicant
- W.O.M. World of Medicine GmbH
- Product code
- Code HIG
- Device class
- Class 2
- Regulation
- 21 CFR 884.1700
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Berlin, DE
Recent devices under product code HIG
view allMore clearances from W.O.M. World of Medicine GmbH
view allAdverse events under product code HIG
product code HIG- Death
- 8
- Other
- 2
- Total
- 10
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K172040
K-number listed on FDA's recall record- Z-2629-2023 — Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
- Z-2767-2019 — Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172040.
Data sourced from openFDA. This site is unofficial and independent of the FDA.