HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000— 510(k) K982867

Substantially Equivalent

Davol Inc., Sub. C. R. Bard, Inc.

FDA 510(k) clearance K982867 for HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000, Substantially Equivalent on 1999-02-19. Applicant: Davol Inc., Sub. C. R. Bard, Inc..

Clearance details

Applicant: Davol Inc., Sub. C. R. Bard, Inc.
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1998-08-14
Decision date: 1999-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canston, RI, US

Download summary PDF View on FDA.gov ↗

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.