K811632

Substantially Equivalent

UNSTERILIZED LAPAROTOMY SPONGES (CHINA)

Applicant: Robert I. Chien & Assoc., Inc.
Product code: GDY
Advisory panel: General, Plastic Surgery
Date received: 1981-06-09
Decision date: 1981-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.