DeviceClearance

PERCUTANEOUS DRAINING CATHETER— 510(k) K811378

Substantially Equivalent

Medi-Tech, Inc.

FDA 510(k) clearance K811378 for PERCUTANEOUS DRAINING CATHETER, Substantially Equivalent on 1981-06-02. Applicant: Medi-Tech, Inc.. Device class: 1.

Clearance details

Applicant
Medi-Tech, Inc.
Product code
Code GBW
Device class
Class 1
Regulation
21 CFR 878.4200
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GBW

product code GBW
Death
6
Total
6

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K811378

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K811378.

Data sourced from openFDA. This site is unofficial and independent of the FDA.