K890658

Substantially Equivalent

SYRINGE INJECTION GUN DELIVERY KITS

Applicant: Gastrotech, Inc.
Product code: LRO
Advisory panel: General, Plastic Surgery
Date received: 1989-02-08
Decision date: 1989-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Independence, OH, US

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.