SURGITEK ULTRA-LO CUFF— 510(k) K830504

Substantially Equivalent

Mec/Surgitek Products

FDA 510(k) clearance K830504 for SURGITEK ULTRA-LO CUFF, Substantially Equivalent on 1983-04-12. Applicant: Mec/Surgitek Products.

Clearance details

Applicant: Mec/Surgitek Products
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1983-02-16
Decision date: 1983-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.