Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly— 510(k) K222232

Substantially Equivalent

Bard Access Systems, Inc.

FDA 510(k) clearance K222232 for Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly, Substantially Equivalent on 2022-08-24. Applicant: Bard Access Systems, Inc..

Clearance details

Applicant: Bard Access Systems, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2022-07-25
Decision date: 2022-08-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake Ciy,, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.