Product code HES— Obstetrics/Gynecology

FDA has cleared 13 devices under product code HES between 1984 and 2014, filed by 12 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.

• 20141 clearance
• 20001 clearance
• 19904 clearances
• 19892 clearances
• 19881 clearance
• 19871 clearance
• 19861 clearance
• 19851 clearance
• 19841 clearance

• Adler Instrument Co.2 clearances
• Zinnanti Surgical Instruments, Inc.1 clearance
• Unimar, Inc.1 clearance
• Rocket Medical Plc1 clearance
• Humi Corp.1 clearance
• F.M. Wiest USA, Inc.1 clearance
• Core Dynamics, Inc.1 clearance
• Cook Ob/Gyn1 clearance
• Carefusion 2200, Inc.1 clearance
• Cabot Medical Corp.1 clearance

• K140761 — KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULACarefusion 2200, Inc.·2014-04-21
• K000340 — HYSTALOG HSG CATHETERRocket Medical Plc·2000-04-19
• K903209 — MAXI-FLOW INSUFFLATOR TUBING SET W/FILTERAdler Instrument Co.·1990-12-21
• K903208 — MAXI-FLOW INSUFFLATOR TUBING SETAdler Instrument Co.·1990-12-17
• K904473 — KRONNER MANIPUJECTORUnimar, Inc.·1990-12-14
• K901413 — CORE DISPOSABLE INSUFFLATION TUBINGCore Dynamics, Inc.·1990-09-24
• K891290 — SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETERCook Ob/Gyn·1989-05-23
• K890869 — BARD HYSTEROSALPINGOGRAPHY CATHETERSC.R. Bard, Inc.·1989-04-25
• K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONICF.M. Wiest USA, Inc.·1988-03-02
• K873515 — UTERINE INJECTOR 2MMZinnanti Surgical Instruments, Inc.·1987-09-29
• K862310 — CABOT MEDICAL VARIABLE FLOW INSUFFLATORCabot Medical Corp.·1986-08-12
• K844173 — FEMTESTBionexus, Inc.·1985-08-14
• K841682 — UTERINE INJECTOR 4.0MMHumi Corp.·1984-07-03