ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)— 510(k) K233113

Substantially Equivalent

Starmed Co., Ltd.

FDA 510(k) clearance K233113 for ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L), Substantially Equivalent on 2023-10-25. Applicant: Starmed Co., Ltd..

Clearance details

Applicant: Starmed Co., Ltd.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2023-09-27
Decision date: 2023-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Goyang-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.