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

Name: FDA 510(k) clearance K991799
Creator: U.S. Food and Drug Administration
Published: 1999-09-13

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.. Device class: 2.

Clearance details

Applicant: Davol Inc., Sub. C. R. Bard, Inc.
Product code: Code HIG
Device class: Class 2
Regulation: 21 CFR 884.1700
Advisory panel: Obstetrics/Gynecology
Date received: 1999-05-26
Decision date: 1999-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canston, RI, US

Download summary PDF View on FDA.gov ↗

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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.