INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER— 510(k) K070151

Substantially Equivalent

Ethicon Endo-Surgery, LLC

FDA 510(k) clearance K070151 for INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER, Substantially Equivalent on 2007-08-15. Applicant: Ethicon Endo-Surgery, LLC.

Clearance details

Applicant: Ethicon Endo-Surgery, LLC
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 2007-01-16
Decision date: 2007-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, 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.