SINGLE ACCESS DEVICE (SSAD)— 510(k) K823715

Substantially Equivalent

Samaritan Hospital

FDA 510(k) clearance K823715 for SINGLE ACCESS DEVICE (SSAD), Substantially Equivalent on 1983-02-07. Applicant: Samaritan Hospital.

Clearance details

Applicant: Samaritan Hospital
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1982-12-10
Decision date: 1983-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.