DOLPHIN 3 FLUID MANAGEMENT SYSTEM— 510(k) K110852
Substantially EquivalentGyrus Acmi, Inc.
FDA 510(k) clearance K110852 for DOLPHIN 3 FLUID MANAGEMENT SYSTEM, Substantially Equivalent on 2011-07-19. Applicant: Gyrus Acmi, Inc.. Device class: 2.
Clearance details
- Applicant
- Gyrus Acmi, 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
- Southborough, MA, US
Recent devices under product code HIG
view allMore clearances from Gyrus Acmi, Inc.
view all- K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
- K233275 — RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) +2 more
- K231327 — POWERSEAL Sealer and Divider
- K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
- K212650 — Celeris, Disposable Sinus Debrider
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.