Product code FLC— Gastroenterology, Urology

COIL MACHINE ADAPTER

Classification name: Station, Dialysis Control, Negative Pressure Type
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Total cleared: 4
First cleared: 1976-10-27
Most recent: 1991-04-25

Market context for product code FLC

FDA has cleared 4 devices under product code FLC between 1976 and 1991, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19911 clearance
19861 clearance
19791 clearance
19761 clearance

Top applicants under product code FLC

Wilson-Cook Medical, Inc.1 clearance
Seratronics, Inc.1 clearance
Medicorp, Inc.1 clearance
Gambro, Inc.1 clearance

Recent clearances under product code FLC

K910656 — WILSON-COOK DISPOSABLE BIOPSY FORCEPSWilson-Cook Medical, Inc.·1991-04-25
K855001 — FRESENIUS HEMODIALYSIS MACHINE A1008 BSMSeratronics, Inc.·1986-01-21
K791164 — NEGATOVE PRESSURE CONVERTORMedicorp, Inc.·1979-10-04
K760725 — COIL MACHINE ADAPTERGambro, Inc.·1976-10-27

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