Product code HGW— Obstetrics/Gynecology

FDA has cleared 4 devices under product code HGW between 1981 and 1989, filed by 2 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
• 19831 clearance
• 19811 clearance

• Transidyne General Corp.3 clearances
• A & A Medical, Inc.1 clearance

• K891388 — 1570 - FETAL BLOOD SAMPLING KITTransidyne General Corp.·1989-03-28
• K884685 — ROCKET FETAL BLOOD SAMPLING TRAYA & A Medical, Inc.·1989-01-12
• K831459 — FETAL BLOOD SAMPLING KIT #1560Transidyne General Corp.·1983-06-30
• K810028 — FETAL BLOOD SAMPLING KIT MODEL 1560Transidyne General Corp.·1981-01-16