REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES— 510(k) K101733

Substantially Equivalent

Sac, LLC Dba Pinnacle Medical Surgical

FDA 510(k) clearance K101733 for REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES, Substantially Equivalent on 2011-06-06. Applicant: Sac, LLC Dba Pinnacle Medical Surgical.

Clearance details

Applicant: Sac, LLC Dba Pinnacle Medical Surgical
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2010-06-21
Decision date: 2011-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, 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.