Product code HFI— Obstetrics/Gynecology

FDA has cleared 8 devices under product code HFI between 1984 and 2015, filed by 7 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.

• 20151 clearance
• 19946 clearances
• 19841 clearance

• Zinnanti Surgical Instruments, Inc.2 clearances
• Snowden-Pencer1 clearance
• Numed Technologies, Inc.1 clearance
• Endoplus1 clearance
• Endo Technic Corp.1 clearance
• Cook Urological, Inc.1 clearance
• Canon USA, Inc.1 clearance

• K151567 — ENDOPLUS hand-held laparoscopic instrumentsEndoplus·2015-12-23
• K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USEZinnanti Surgical Instruments, Inc.·1994-06-07
• K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USEZinnanti Surgical Instruments, Inc.·1994-06-07
• K936026 — COOK LAPAROSCOPIC MINI RETRACTOR SETCook Urological, Inc.·1994-03-11
• K924148 — DIAMOND-SHARP(R) TROCARSSnowden-Pencer·1994-02-28
• K925114 — LAPAROSCOPIC INSTRUMENTSEndo Technic Corp.·1994-02-28
• K930571 — REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATINGNumed Technologies, Inc.·1994-02-01
• K844053 — CANON 60 DEGREE FUNDUS CAMERA CF-60SCanon USA, Inc.·1984-12-19