SUTURE REMOVAL TRAY, REORDER 7950&7951— 510(k) K791889

Substantially Equivalent

Ascep, Inc.

FDA 510(k) clearance K791889 for SUTURE REMOVAL TRAY, REORDER 7950&7951, Substantially Equivalent on 1979-10-17. Applicant: Ascep, Inc..

Clearance details

Applicant
Ascep, Inc.
Product code
Code FSM
Advisory panel
General, Plastic Surgery
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 FSM

product code FSM
Malfunction
1,289
Total
1,289

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.