Product code HFD— Obstetrics/Gynecology

FDA has cleared 3 devices under product code HFD between 1981 and 1989, 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.

• 19892 clearances
• 19811 clearance

• Zinnanti Surgical Instruments, Inc.1 clearance
• Kinetic Medical Products1 clearance
• Associated Medical Products Co.1 clearance

• K891037 — WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUEZinnanti Surgical Instruments, Inc.·1989-03-17
• K890376 — VAGINAL SPECULUMKinetic Medical Products·1989-02-27
• K810558 — SKIN SCRUB TRAYAssociated Medical Products Co.·1981-03-17