EDGE MEDICAL DISPENSING PIN— 510(k) K921031

Substantially Equivalent

Edgewater Medical Center

FDA 510(k) clearance K921031 for EDGE MEDICAL DISPENSING PIN, Substantially Equivalent on 1992-10-19. Applicant: Edgewater Medical Center.

Clearance details

Applicant: Edgewater Medical Center
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1992-03-03
Decision date: 1992-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly Hills, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.