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FAQ

18 FDA 510(k) clearances · Product code

66 daysmedian time to decision
142 days90th percentile
18clearances measured

FDA profile

Official device name
Bag, Urine Collection, Leg, For External Use, Sterile
Device class
Class I (low risk)
Regulation
21 CFR 876.5250
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2016: 13 · 2017: 22 · 2021: 70 · 2022: 48 · 2023: 36 · 2024: 42
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING (K962604)Convatec, A Division of E.R. Squibb & Sons1996-07-18
CPR URINE BAG (K960217)Custom Pack Reliability1996-03-28
CONVEEN URINE BAG - STERILE (K955609)Coloplast Corp.1995-12-29
PROSYS BEDSIDE DRAINAGE BAG (K953767)Convatec, A Division of E.R. Squibb & Sons1995-12-20
CONVEEN LEG BAG STRAP (K953783)Coloplast Corp.1995-09-13
PROSYS LEG BAG (K951945)Convatec, A Division of E.R. Squibb & Sons1995-05-25
URINE COLLECTOR & ACCESSORIES (K945204)Nelmed Corp.1994-11-02
ALPINE REUSABLE LEG BAGS (K934052)Sierra Laboratories, Inc.1994-01-07
URINARY DRAINAGE BAG CADDY (K931727)Neotech Products, Inc.1993-07-23
BARD LEG BAG HOLDER (K926035)C.R. Bard, Inc.1992-12-17
CONVEEN(R) LEG BAG(500 ML) (K924406)Coloplast A/S1992-10-30
ILC LEG BAG HOLDER (K903611)Inman Liebelt Corp.1990-10-26
EXTERNAL LEG BAG (K901219)Orion Life Systems, Inc.1990-06-27
URINARY LEG BAG (K896129)Cypress Medical Products, Ltd.1990-04-16
4 SURE URINARY LEG BAG (K896728)The Boston & Pacific Co., Inc.1990-02-20
CATHETER STRAP & RUINARY BAY HOLDER (K780190)Baka Manufacturing Co., Inc.1978-02-21
QUADRIPLEGIC URINARY DRAINAGE VALVE (K772402)Fred Sammons, Inc.1978-01-26
URINARY LEG BAG (K780032)C.R. Bard, Inc.1978-01-17

Track FAQ automatically

Every clearance here is in the API, with alerts when new ones post.