Product code HFC— Obstetrics/Gynecology

FDA has cleared 11 devices under product code HFC between 1980 and 1997, filed by 10 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.

• 19971 clearance
• 19962 clearances
• 19951 clearance
• 19903 clearances
• 19891 clearance
• 19821 clearance
• 19811 clearance
• 19801 clearance

• Cook Urological, Inc.2 clearances
• Unimar, Inc.1 clearance
• Select Medical Systems, Inc.1 clearance
• Seamless Hospital Products Co.1 clearance
• Robert Hasselbrack, M.D.1 clearance
• Permobil AB1 clearance
• Innovative Medical Products, Inc.1 clearance
• Fertility Instrumentation, Inc.1 clearance
• Customed, Inc.1 clearance
• A & A Medical, Inc.1 clearance

• K974032 — ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATORA & A Medical, Inc.·1997-12-22
• K960263 — CERVICAL MUCOUS ASPIRATION CATHETERCook Urological, Inc.·1996-08-29
• K954903 — PEDI VAGINAL ASPIRATORCook Urological, Inc.·1996-04-29
• K954102 — SELECTMUCUSSelect Medical Systems, Inc.·1995-11-21
• K902242 — ENDOCERVICAL ASPIRATORInnovative Medical Products, Inc.·1990-10-09
• K902032 — O. B. PACK IVCustomed, Inc.·1990-09-28
• K902954 — OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)Permobil AB·1990-08-23
• K895403 — ASPIRETTE ENDOCERVICAL ASPIRATORUnimar, Inc.·1989-11-29
• K821134 — DC PACK TMSeamless Hospital Products Co.·1982-06-22
• K812175 — ENDOCERVICAL ASPIRATORFertility Instrumentation, Inc.·1981-09-21
• K801238 — ACCU-PAP T ZONE SAMPLERRobert Hasselbrack, M.D.·1980-08-12