PELVX DONUT, PELVX CUBE— 510(k) K974117

Name: FDA 510(k) clearance K974117
Creator: U.S. Food and Drug Administration
Published: 1998-04-27

Substantially Equivalent

Deschutes Medical Products, Inc.

FDA 510(k) clearance K974117 for PELVX DONUT, PELVX CUBE, Substantially Equivalent on 1998-04-27. Applicant: Deschutes Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Deschutes Medical Products, Inc.
Product code: Code HHW
Device class: Class 2
Regulation: 21 CFR 884.3575
Advisory panel: Obstetrics/Gynecology
Date received: 1997-10-31
Decision date: 1998-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bend, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HHW

product code HHW

Malfunction: 485
Total: 485

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.