SUPERSTITCH— 510(k) K994087

Substantially Equivalent

Sutura, Inc.

FDA 510(k) clearance K994087 for SUPERSTITCH, Substantially Equivalent on 2000-03-01. Applicant: Sutura, Inc..

Clearance details

Applicant: Sutura, Inc.
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 1999-12-03
Decision date: 2000-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fountain Valley, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

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.