Bag, Urine Collection, Leg, For External Use, Sterile
The Sterile Leg Urine Collection Bag for External Use (product code FAQ) is a wearable urine collection bag secured to the leg, intended for patients who require external urinary drainage without an indwelling catheter. It is an FDA Class 1 device (lowest risk), subject only to general controls with no premarket notification required. It is regulated under 21 CFR 876.5250 in the Gastroenterology and Urology specialty. No special flags apply.
Basic Information
- Product Code
- FAQ
- Device Class
- FDA class 1
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K962604 | PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING | Jul 18, 1996 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K960217 | CPR URINE BAG | Mar 28, 1996 | Substantially Equivalent | CUSTOM PACK RELIABILITY |
| K955609 | CONVEEN URINE BAG - STERILE | Dec 29, 1995 | Substantially Equivalent | COLOPLAST CORP. |
| K953767 | PROSYS BEDSIDE DRAINAGE BAG | Dec 20, 1995 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K953783 | CONVEEN LEG BAG STRAP | Sep 13, 1995 | Substantially Equivalent | COLOPLAST CORP. |
| K951945 | PROSYS LEG BAG | May 25, 1995 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K945204 | URINE COLLECTOR & ACCESSORIES | Nov 02, 1994 | Substantially Equivalent | NELMED CORP. |
| K934052 | ALPINE REUSABLE LEG BAGS | Jan 07, 1994 | Substantially Equivalent | SIERRA LABORATORIES, INC. |
| K931727 | URINARY DRAINAGE BAG CADDY | Jul 23, 1993 | Substantially Equivalent | NEOTECH PRODUCTS, INC. |
| K926035 | BARD LEG BAG HOLDER | Dec 17, 1992 | Substantially Equivalent | C.R. BARD, INC. |
| K924406 | CONVEEN(R) LEG BAG(500 ML) | Oct 30, 1992 | Substantially Equivalent | COLOPLAST A/S |
| K903611 | ILC LEG BAG HOLDER | Oct 26, 1990 | Substantially Equivalent | INMAN LIEBELT CORP. |
| K901219 | EXTERNAL LEG BAG | Jun 27, 1990 | Substantially Equivalent | ORION LIFE SYSTEMS, INC. |
| K896129 | URINARY LEG BAG | Apr 16, 1990 | Substantially Equivalent | CYPRESS MEDICAL PRODUCTS, LTD. |
| K896728 | 4 SURE URINARY LEG BAG | Feb 20, 1990 | Substantially Equivalent | THE BOSTON & PACIFIC CO., INC. |
| K780190 | CATHETER STRAP & RUINARY BAY HOLDER | Feb 21, 1978 | Substantially Equivalent | BAKA MANUFACTURING CO., INC. |
| K772402 | QUADRIPLEGIC URINARY DRAINAGE VALVE | Jan 26, 1978 | Substantially Equivalent | FRED SAMMONS, INC. |
| K780032 | URINARY LEG BAG | Jan 17, 1978 | Substantially Equivalent | C.R. BARD, INC. |
FEI Numbers
This FDA classification entry is associated with 115 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 115 registration numbers. Click on an entry to view related FDA registrations.