REALHAND HIGH DEXTERITY INSTRUMENTS— 510(k) K072715

Substantially Equivalent

Novare Surgical Systems, Inc.

FDA 510(k) clearance K072715 for REALHAND HIGH DEXTERITY INSTRUMENTS, Substantially Equivalent on 2007-10-16. Applicant: Novare Surgical Systems, Inc..

Clearance details

Applicant: Novare Surgical Systems, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2007-09-25
Decision date: 2007-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.