Product code HFN— Obstetrics/Gynecology

FDA has cleared 9 devices under product code HFN between 1989 and 2025, filed by 5 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.

• 20251 clearance
• 19981 clearance
• 19971 clearance
• 19963 clearances
• 19921 clearance
• 19892 clearances

• Clinical Innovations, Inc.3 clearances
• Utah Medical Products, Inc.2 clearances
• Telos Medical Corp.2 clearances
• Laurel Medical Corp.1 clearance
• Clinical Innovations, LLC1 clearance

• K250897 — Koala Intrauterine Pressure Catheter (IPC-5000E)Clinical Innovations, LLC·2025-05-22
• K974389 — KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.·1998-02-19
• K973746 — PRE-FILLED SYRINGE FOR KOALA IUPClinical Innovations, Inc.·1997-11-24
• K961424 — INTRAN 500Utah Medical Products, Inc.·1996-07-10
• K954955 — STORC INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.·1996-04-17
• K955443 — INTRAN PLUSUtah Medical Products, Inc.·1996-02-20
• K920375 — DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCERTelos Medical Corp.·1992-10-27
• K882224 — ULTRANS DISPOSABLE INTRAUTERINETelos Medical Corp.·1989-10-12
• K893503 — SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANSLaurel Medical Corp.·1989-06-12