Product code HFG— Obstetrics/Gynecology

FDA has cleared 11 devices under product code HFG between 1990 and 2018, filed by 8 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.

• 20181 clearance
• 20142 clearances
• 20121 clearance
• 20101 clearance
• 19991 clearance
• 19961 clearance
• 19941 clearance
• 19921 clearance
• 19911 clearance
• 19901 clearance

• Halt Medical, Inc.3 clearances
• Davol, Inc.2 clearances
• Ratio Design Lab1 clearance
• Medicor Corp.1 clearance
• Mcgan Technology, LLC1 clearance
• Intl. Medical, Inc.1 clearance
• Aspen Labs1 clearance
• Acessa Health, Inc.1 clearance

Death

3

Injury

121

Total

124

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K181124 — Acessa ProVu SystemAcessa Health, Inc.·2018-09-28
• K132744 — ACESSA GUIDANCE SYSTEMHalt Medical, Inc.·2014-05-27
• K132184 — ACESSA GUIDANCE HANDPIECEHalt Medical, Inc.·2014-04-28
• K121858 — THE ABLATION SYSTEMHalt Medical, Inc.·2012-11-05
• K101606 — MICROMED PD-8K INSULATION DEFECT DETECTORMcgan Technology, LLC·2010-10-01
• K991424 — INSULSCAN INSULATION TESTING SYSTEMMedicor Corp.·1999-07-22
• K961695 — ENDO-TECH LTD., TIPSRatio Design Lab·1996-07-01
• K921405 — DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIPDavol, Inc.·1994-03-25
• K915406 — DAVOL ELECTROSUGICAL PROBESDavol, Inc.·1992-02-28
• K904240 — SINGLE USE LAPARSCOPIC ELECTRODEAspen Labs·1991-02-19
• K902555 — AMCATH COAGULATION PROBEIntl. Medical, Inc.·1990-06-20