Product code HFE— Obstetrics/Gynecology

FDA has cleared 9 devices under product code HFE between 1985 and 2024, 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.

• 20241 clearance
• 20171 clearance
• 20121 clearance
• 20081 clearance
• 19951 clearance
• 19941 clearance
• 19901 clearance
• 19881 clearance
• 19851 clearance

• Cook Ob/Gyn2 clearances
• Utepreva, LLC1 clearance
• Post Oak Innovations, Inc.1 clearance
• Laboratoire Ccd C/O Washington Regulatory Services1 clearance
• Intl. Cytobrush, Inc.1 clearance
• Gyneco, Inc.1 clearance
• Cook Urological, Inc.1 clearance
• Cook Incorporated1 clearance

• K240595 — Utepreva Endometrial Sampler (UP01)Utepreva, LLC·2024-08-14
• K170603 — Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated·2017-05-24
• K112763 — MATRIXBRUSH ENDOMETRIAL SAMPLERPost Oak Innovations, Inc.·2012-06-18
• K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERCook Urological, Inc.·2008-11-07
• K941298 — IUMC ENDOMETRIAL SAMPLERCook Ob/Gyn·1995-02-13
• K911620 — STOVALL ENDOMETRIAL BRUSHCook Ob/Gyn·1994-06-24
• K897070 — ENDOBRUSH(TM) DEVICE; OMNIBRUSHIntl. Cytobrush, Inc.·1990-09-10
• K881220 — ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLERLaboratoire Ccd C/O Washington Regulatory Services·1988-06-14
• K843941 — ENDOCYTEGyneco, Inc.·1985-02-25