Product code EXF— Gastroenterology, Urology

FDA has cleared 9 devices under product code EXF between 1990 and 2000, 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.

• 20001 clearance
• 19991 clearance
• 19981 clearance
• 19971 clearance
• 19961 clearance
• 19941 clearance
• 19911 clearance
• 19902 clearances

• Uresil Corp.2 clearances
• Manan Medical Products, Inc.2 clearances
• Remington Medical, Inc.1 clearance
• Navarre Biomedical , Ltd.1 clearance
• Merit Medical Systems, Inc.1 clearance
• Medical Technologies of Georgia1 clearance
• Medical Device Technologies, Inc.1 clearance

• K003078 — MERIT DRAINAGE DEPOTMerit Medical Systems, Inc.·2000-12-11
• K990428 — DRAINAGE BAGRemington Medical, Inc.·1999-08-12
• K980005 — MANAN D BAGMedical Device Technologies, Inc.·1998-01-30
• K961986 — MANAN D BAGManan Medical Products, Inc.·1997-03-13
• K963849 — MANAN D BAGManan Medical Products, Inc.·1996-12-13
• K943663 — NAVARRE 600 ML DRAINAGE BAGNavarre Biomedical , Ltd.·1994-09-08
• K911129 — MMG BILE BAGMedical Technologies of Georgia·1991-08-07
• K903449 — URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SETUresil Corp.·1990-09-12
• K901844 — URESIL TRU-CLOSE DRAINAGE BAGUresil Corp.·1990-06-01