SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE— 510(k) K944292

Substantially Equivalent

Surgical Innovations Corp.

FDA 510(k) clearance K944292 for SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE, Substantially Equivalent on 1994-11-15. Applicant: Surgical Innovations Corp..

Clearance details

Applicant: Surgical Innovations Corp.
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-02
Decision date: 1994-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Claremont, NH, US

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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.