PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301— 510(k) K123110

Substantially Equivalent

Surgical Innovations Plc

FDA 510(k) clearance K123110 for PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301, Substantially Equivalent on 2013-01-17. Applicant: Surgical Innovations Plc.

Clearance details

Applicant: Surgical Innovations Plc
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2012-10-03
Decision date: 2013-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Leeds, W. Yorkshire, GB

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.