SYN-OPTICS #5200— 510(k) K820624

Substantially Equivalent

Syn-Optics

FDA 510(k) clearance K820624 for SYN-OPTICS #5200, Substantially Equivalent on 1982-04-01. Applicant: Syn-Optics.

Clearance details

Applicant: Syn-Optics
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 1982-03-08
Decision date: 1982-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.