AQUASENS FLUID MONITORING SYSTEM— 510(k) K031213
Substantially EquivalentDavol, Inc.
FDA 510(k) clearance K031213 for AQUASENS FLUID MONITORING SYSTEM, Substantially Equivalent on 2003-04-30. Applicant: Davol, Inc.. Device class: 2.
Clearance details
- Applicant
- Davol, Inc.
- 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
- Traditional
- Location
- Cranston, RI, US
Recent devices under product code HIG
view allMore clearances from Davol, Inc.
view all- K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped
- K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
- K030307 — DAVOL ARTHROVENT OUTFLOW TUBING
- K003323 — COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
- K003790 — DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.