Product code HIC— Obstetrics/Gynecology

FDA has cleared 5 devices under product code HIC between 1985 and 1996, filed by 5 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.

• 19961 clearance
• 19941 clearance
• 19902 clearances
• 19851 clearance

• Trylon Corp.1 clearance
• Trylon Associates, Ltd.1 clearance
• Tri-State Hospital Supply Corp.1 clearance
• Sims Surgical, Inc.1 clearance
• Galenica Enterprises, Inc.1 clearance

• K955790 — PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAYTrylon Corp.·1996-03-21
• K923656 — LIGHTING SOURCE SYSTEMGalenica Enterprises, Inc.·1994-09-08
• K902516 — NEW LENGTH SUGITA APPLIERSSims Surgical, Inc.·1990-07-03
• K897100 — CENTURION VAGINAL SPECULUMTri-State Hospital Supply Corp.·1990-03-16
• K853257 — SPECULITE DISPOSABLE VAGINAL LIGHTTrylon Associates, Ltd.·1985-12-27