Product code FFZ— Gastroenterology, Urology

ACEM

Classification name: Cord, Electric, For Endoscope
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Total cleared: 3
First cleared: 1979-01-10
Most recent: 2011-12-19

Market context for product code FFZ

FDA has cleared 3 devices under product code FFZ between 1979 and 2011, filed by 3 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

20111 clearance
19821 clearance
19791 clearance

Top applicants under product code FFZ

Sandhill Scientific, Inc.1 clearance
Kelleher Corp.1 clearance
Concept, Inc.1 clearance

Recent clearances under product code FFZ

K111013 — ACEMSandhill Scientific, Inc.·2011-12-19
K822254 — ELECTRIC CORD FOR ENDOSCOPEKelleher Corp.·1982-08-20
K782046 — C-CORDConcept, Inc.·1979-01-10

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