Product code MKO— Obstetrics/Gynecology

FDA has cleared 4 devices under product code MKO between 1997 and 2023, filed by 3 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.

• 20231 clearance
• 19981 clearance
• 19972 clearances

• Conceptus, Inc.2 clearances
• Imagyn Medical, Inc.1 clearance
• Femdx Medsystems, Inc.1 clearance

• K221965 — FemDx FalloViewFemdx Medsystems, Inc.·2023-03-17
• K974028 — STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBINGConceptus, Inc.·1998-01-21
• K962587 — CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEMConceptus, Inc.·1997-01-31
• K963580 — IMAGYN FALLOPOSCOPY SYSTEMImagyn Medical, Inc.·1997-01-31