SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE— 510(k) K113763

Substantially Equivalent

Nobles Medical Technologies Ii, Inc.

FDA 510(k) clearance K113763 for SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE, Substantially Equivalent on 2012-03-16. Applicant: Nobles Medical Technologies Ii, Inc..

Clearance details

Applicant: Nobles Medical Technologies Ii, Inc.
Product code: Code GAW
Advisory panel: General, Plastic Surgery
Date received: 2011-12-21
Decision date: 2012-03-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Fountain Valley, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.