EGIS Biliary Single Bare Stent— 510(k) K223354

Unknown

S&G Biotech, Inc.

FDA 510(k) clearance K223354 for EGIS Biliary Single Bare Stent, Unknown on 2023-09-21. Applicant: S&G Biotech, Inc..

Clearance details

Applicant: S&G Biotech, Inc.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2022-11-02
Decision date: 2023-09-21
Decision: Unknown
Clearance type: Traditional
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.