BURNEY GALLBLADDER CATHETER KIT— 510(k) K880343

Name: FDA 510(k) clearance K880343
Creator: U.S. Food and Drug Administration
Published: 1989-05-01

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K880343 for BURNEY GALLBLADDER CATHETER KIT, Substantially Equivalent on 1989-05-01. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code FGE
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 1988-01-26
Decision date: 1989-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Louis, MO, US

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K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR1988-01-06
K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)1987-11-06
K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR1987-11-06

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.