PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,— 510(k) K844876

Substantially Equivalent

Pennine Medical , Ltd.

FDA 510(k) clearance K844876 for PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,, Substantially Equivalent on 1985-06-05. Applicant: Pennine Medical , Ltd..

Clearance details

Applicant: Pennine Medical , Ltd.
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1984-12-17
Decision date: 1985-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Derby, GB

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Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.