Burney Gallbladder Catheter Kit

by Mallinckrodt Critical Care 510(k)

Active United States

510(k) K880343

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK880343	Date1 May 1989Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K880343
FDA Product Code: FGE

Device Class: Class II
Regulation: 21 CFR Part 876.5010
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

Other devices from Mallinckrodt Critical Care

Foam Nose

Class I
Isotonic Diluent

Class I
Hi-Lo Temp Thermocouple to Thermister Adaptor

Class II
Glucose Reagent (O-Toluidine)

Class II
Ria Quant C-Peptide Kit

Class I
Hi-Lo Temp(R) Model 8700 Patient Temp Monitor

Class II

See all devices from Mallinckrodt Critical Care →