DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2— 510(k) K011876

Substantially Equivalent

Circon Video

FDA 510(k) clearance K011876 for DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2, Substantially Equivalent on 2002-01-08. Applicant: Circon Video.

Clearance details

Applicant: Circon Video
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 2001-06-15
Decision date: 2002-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Framingham, MA, US

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Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.