TUBE, LEATHERMAN/IMBRUCE— 510(k) K781665

Name: FDA 510(k) clearance K781665
Creator: U.S. Food and Drug Administration
Published: 1978-12-15

Substantially Equivalent

National Catheter Co. Div. Mallinckrodt

FDA 510(k) clearance K781665 for TUBE, LEATHERMAN/IMBRUCE, Substantially Equivalent on 1978-12-15. Applicant: National Catheter Co. Div. Mallinckrodt. Device class: 1.

Clearance details

Applicant: National Catheter Co. Div. Mallinckrodt
Product code: Code GBA
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1978-09-28
Decision date: 1978-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K802918 — ANTHRON CATHETER SET1981-04-21
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K801924 — HI-LO TEMP GEN. PURPOSE TEMP. PROBE1980-09-09
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Adverse events under product code GBA

product code GBA

Death: 2
Total: 2

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.