BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT— 510(k) K993138

Substantially Equivalent

Ballard Medical Products

FDA 510(k) clearance K993138 for BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT, Substantially Equivalent on 1999-10-20. Applicant: Ballard Medical Products.

Clearance details

Applicant: Ballard Medical Products
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1999-09-20
Decision date: 1999-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Draper, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.