Product code HGF— Obstetrics/Gynecology

FDA has cleared 4 devices under product code HGF between 1989 and 1995, 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.

• 19951 clearance
• 19911 clearance
• 19901 clearance
• 19891 clearance

• Medgyn Products, Inc.1 clearance
• Hgm Medical Laser Systems, Inc.1 clearance
• Douglas James Donaldson Compliance Services1 clearance
• Charles L. Rose and Co., Inc.1 clearance

• K945179 — BOTTLE COLLECTION SETMedgyn Products, Inc.·1995-01-26
• K905115 — BIOVISION ENDOCULAR PROBEDouglas James Donaldson Compliance Services·1991-02-11
• K904248 — MODEL GLASE 210 HOLMIUM LASER SYSTEMCharles L. Rose and Co., Inc.·1990-12-14
• K890787 — O-020 LASER INDIRECT OPHTHALMOSCOPEHgm Medical Laser Systems, Inc.·1989-03-24