Product code HFF— Obstetrics/Gynecology

FDA has cleared 5 devices under product code HFF between 1982 and 2004, 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.

• 20041 clearance
• 19912 clearances
• 19841 clearance
• 19821 clearance

• Axcan Scientific Corp.2 clearances
• Wallach Surgical Devices, Inc.1 clearance
• Gynopharma, Inc.1 clearance
• Gynetics Medical Products NV1 clearance

• K041237 — ECHOSAMPLERGynetics Medical Products NV·2004-09-08
• K903002 — PROBET (TM)Gynopharma, Inc.·1991-04-05
• K902693 — WALLACH FLEXIBLE ENDOMETRIAL SAMPLERWallach Surgical Devices, Inc.·1991-01-31
• K831212 — ENDOSCANNAxcan Scientific Corp.·1984-06-15
• K820641 — ACCURETTEAxcan Scientific Corp.·1982-06-22