DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO— 510(k) K991799

Substantially Equivalent

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

FDA 510(k) clearance K991799 for DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO, Substantially Equivalent on 1999-09-13. 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: 1999-05-26
Decision date: 1999-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canston, RI, 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.