Product code HGP— Obstetrics/Gynecology

FDA has cleared 17 devices under product code HGP between 1977 and 2025, filed by 13 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.

• 20251 clearance
• 20031 clearance
• 20011 clearance
• 19941 clearance
• 19915 clearances
• 19901 clearance
• 19872 clearances
• 19851 clearance
• 19831 clearance
• 19802 clearances
• 19771 clearance

• Graphic Controls Corp.3 clearances
• Medical Accessories, Inc.2 clearances
• Clinical Innovations, Inc.2 clearances
• Utah Medical Products, Inc.1 clearance
• Neward Enterprises, Inc.1 clearance
• Neoventa Medical AB1 clearance
• Life Support, Inc.1 clearance
• Kontron Instruments, Inc.1 clearance
• Hewlett-Packard Co.1 clearance
• Ge Medical Systems Information Technologies1 clearance

• K243291 — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)Neoventa Medical AB·2025-01-17
• K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE07000Clinical Innovations, Inc.·2003-09-17
• K003458 — SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000Clinical Innovations, Inc.·2001-05-03
• K943732 — LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCEGraphic Controls Corp.·1994-10-20
• K910815 — CR SPIRAL ELECTRODENeward Enterprises, Inc.·1991-12-10
• K911657 — FETAL SCALP SPIRAL ELECTRODEAdvanced Medical Systems, Inc.·1991-07-11
• K905830 — COMBO FETAL SCALP ELECTRODE/LEGPLATEUtah Medical Products, Inc.·1991-03-29
• K904745 — MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODEGraphic Controls Corp.·1991-01-29
• K905130 — FETAL MONITORING SPIRAL ELECTRODEGraphic Controls Corp.·1991-01-29
• K901152 — REDYPLATE DISPOSABLE LEG PLATEMedical Accessories, Inc.·1990-04-04
• K872057 — FETAL SCALP ELECTRODEMedical Accessories, Inc.·1987-11-16
• K871079 — FETALFLEX FETAL ELECTRODEEpcom Medical Systems, Inc.·1987-07-13
• K844608 — SURGICRAFT COPELAND DISPOSABLEA.W. Showell (Surgicraft) , Ltd.·1985-05-01
• K822584 — MULTI-PRONG FETAL SCALP ELECTRODEKontron Instruments, Inc.·1983-02-24
• K801984 — FE-3000 FETAL ELECTRODE, SPIRAL SYSTEMLife Support, Inc.·1980-09-09
• K792669 — COROMETRICS-PUSH BUTTON SPIRAL ELECTRODEGe Medical Systems Information Technologies·1980-02-11
• K771553 — SPIRAL SCALP ELECTRODE, 14499AHewlett-Packard Co.·1977-08-25