Product code EXI— Gastroenterology, Urology

FDA has cleared 7 devices under product code EXI between 1992 and 1997, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19973 clearances
• 19932 clearances
• 19922 clearances

• Hollister, Inc.2 clearances
• Convatec, A Division of E.R. Squibb & Sons2 clearances
• Mediquest, Inc.1 clearance
• Coloplast A/S1 clearance
• Bioderm, Inc.1 clearance

• K971499 — FEMALE EXTERNAL URINARY COLLECTION POUCHMediquest, Inc.·1997-08-28
• K970443 — HOLLISTER RETRACTED PENIS POUCHHollister, Inc.·1997-02-25
• K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICEBioderm, Inc.·1997-01-10
• K931277 — HOLLISTER PREMIUM URINE COLLECTORHollister, Inc.·1993-06-23
• K924755 — CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTIONConvatec, A Division of E.R. Squibb & Sons·1993-06-22
• K915246 — CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)Coloplast A/S·1992-02-05
• K915616 — URIHESIVE STRIPConvatec, A Division of E.R. Squibb & Sons·1992-01-23