T-M (TIME-MOTION) OPTION— 510(k) K761139

Substantially Equivalent

G.D. Searle and Co.

FDA 510(k) clearance K761139 for T-M (TIME-MOTION) OPTION, Substantially Equivalent on 1976-12-16. Applicant: G.D. Searle and Co..

Clearance details

Applicant
G.D. Searle and Co.
Product code
Code HGM
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HGM

product code HGM
Death
35
Malfunction
478
Total
513

Source: openFDA MAUDE database, through . 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.