INSUFFLATION TUBING STERILE AND NON-STERILE— 510(k) K935639

Substantially Equivalent

Charles Polo & Co., Inc.

FDA 510(k) clearance K935639 for INSUFFLATION TUBING STERILE AND NON-STERILE, Substantially Equivalent on 1994-03-17. Applicant: Charles Polo & Co., Inc..

Clearance details

Applicant: Charles Polo & Co., Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1993-11-23
Decision date: 1994-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, 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.