NASOGASTRIC TUBE HOLDER, MODEL 160— 510(k) K994300

Substantially Equivalent

Dale Medical Products, Inc.

FDA 510(k) clearance K994300 for NASOGASTRIC TUBE HOLDER, MODEL 160, Substantially Equivalent on 2000-02-10. Applicant: Dale Medical Products, Inc..

Clearance details

Applicant: Dale Medical Products, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1999-12-21
Decision date: 2000-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainville, MA, 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.