Product code FAQ— Gastroenterology, Urology

FDA has cleared 18 devices under product code FAQ between 1978 and 1996, filed by 14 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.

• 19962 clearances
• 19954 clearances
• 19942 clearances
• 19931 clearance
• 19922 clearances
• 19904 clearances
• 19783 clearances

• Convatec, A Division of E.R. Squibb & Sons3 clearances
• Coloplast Corp.2 clearances
• C.R. Bard, Inc.2 clearances
• The Boston & Pacific Co., Inc.1 clearance
• Sierra Laboratories, Inc.1 clearance
• Orion Life Systems, Inc.1 clearance
• Neotech Products, Inc.1 clearance
• Nelmed Corp.1 clearance
• Inman Liebelt Corp.1 clearance
• Fred Sammons, Inc.1 clearance

• K962604 — PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZINGConvatec, A Division of E.R. Squibb & Sons·1996-07-18
• K960217 — CPR URINE BAGCustom Pack Reliability·1996-03-28
• K955609 — CONVEEN URINE BAG - STERILEColoplast Corp.·1995-12-29
• K953767 — PROSYS BEDSIDE DRAINAGE BAGConvatec, A Division of E.R. Squibb & Sons·1995-12-20
• K953783 — CONVEEN LEG BAG STRAPColoplast Corp.·1995-09-13
• K951945 — PROSYS LEG BAGConvatec, A Division of E.R. Squibb & Sons·1995-05-25
• K945204 — URINE COLLECTOR & ACCESSORIESNelmed Corp.·1994-11-02
• K934052 — ALPINE REUSABLE LEG BAGSSierra Laboratories, Inc.·1994-01-07
• K931727 — URINARY DRAINAGE BAG CADDYNeotech Products, Inc.·1993-07-23
• K926035 — BARD LEG BAG HOLDERC.R. Bard, Inc.·1992-12-17
• K924406 — CONVEEN(R) LEG BAG(500 ML)Coloplast A/S·1992-10-30
• K903611 — ILC LEG BAG HOLDERInman Liebelt Corp.·1990-10-26
• K901219 — EXTERNAL LEG BAGOrion Life Systems, Inc.·1990-06-27
• K896129 — URINARY LEG BAGCypress Medical Products, Ltd.·1990-04-16
• K896728 — 4 SURE URINARY LEG BAGThe Boston & Pacific Co., Inc.·1990-02-20
• K780190 — CATHETER STRAP & RUINARY BAY HOLDERBaka Manufacturing Co., Inc.·1978-02-21
• K772402 — QUADRIPLEGIC URINARY DRAINAGE VALVEFred Sammons, Inc.·1978-01-26
• K780032 — URINARY LEG BAGC.R. Bard, Inc.·1978-01-17