SURGIFLATOR-40— 510(k) K001533

Substantially Equivalent

W.O.M. Gmhb

FDA 510(k) clearance K001533 for SURGIFLATOR-40, Substantially Equivalent on 2000-07-31. Applicant: W.O.M. Gmhb.

Clearance details

Applicant: W.O.M. Gmhb
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2000-05-17
Decision date: 2000-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.