Product code HDP— Obstetrics/Gynecology

FDA has cleared 4 devices under product code HDP between 1982 and 1998, 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.

• 19982 clearances
• 19881 clearance
• 19821 clearance

• Zinnanti Surgical Instruments, Inc.1 clearance
• Conkin Surgical Instruments , Ltd.1 clearance
• Clinical Innovations, Inc.1 clearance
• Bivona Medical Technologies1 clearance

• K974801 — SINGLE CHANNEL BALLOON CANNULAConkin Surgical Instruments , Ltd.·1998-07-09
• K974563 — COLPO CUP CVC-2000Clinical Innovations, Inc.·1998-03-02
• K882054 — HYSTERO KITZinnanti Surgical Instruments, Inc.·1988-09-29
• K820672 — HASSON BUEC-3Bivona Medical Technologies·1982-07-30