Product code HDQ— Obstetrics/Gynecology

FDA has cleared 6 devices under product code HDQ between 1979 and 1994, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19941 clearance
• 19901 clearance
• 19892 clearances
• 19811 clearance
• 19791 clearance

• Zinnanti Surgical Instruments, Inc.1 clearance
• Thomasville Medical Assoc.1 clearance
• Kinetic Medical Products1 clearance
• Gynemetrics, Inc.1 clearance
• Cook Ob/Gyn1 clearance
• Cavitron Corp.1 clearance

• K930034 — CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTONThomasville Medical Assoc.·1994-02-24
• K896701 — TEFLON CERVICAL ACCESS SETCook Ob/Gyn·1990-09-13
• K891029 — CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALLZinnanti Surgical Instruments, Inc.·1989-03-17
• K890377 — FIXED-SIZE UTERINE DILATORKinetic Medical Products·1989-02-13
• K811568 — CERVICAL DILATORGynemetrics, Inc.·1981-07-16
• K791277 — MODEL 6500 EXTRACTION IRRIGATION SYSCavitron Corp.·1979-08-22