StitchKit— 510(k) K221527

Substantially Equivalent

Origami Surgical Inc .

FDA 510(k) clearance K221527 for StitchKit, Substantially Equivalent on 2023-02-14. Applicant: Origami Surgical Inc ..

Clearance details

Applicant: Origami Surgical Inc .
Product code: Code GAM
Advisory panel: General, Plastic Surgery
Date received: 2022-05-26
Decision date: 2023-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAM

product code GAM

Death: 45
Injury: 5,711
Malfunction: 30,744
Other: 4
Total: 36,504

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.