Product code FAQ
- Device name
- Bag, Urine Collection, Leg, For External Use, Sterile
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5250
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962604 | PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING | Convatec, A Division of E.R. Squibb & Sons | 1996-07-18 |
| K960217 | CPR URINE BAG | Custom Pack Reliability | 1996-03-28 |
| K955609 | CONVEEN URINE BAG - STERILE | Coloplast Corp. | 1995-12-29 |
| K953767 | PROSYS BEDSIDE DRAINAGE BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-12-20 |
| K953783 | CONVEEN LEG BAG STRAP | Coloplast Corp. | 1995-09-13 |
| K951945 | PROSYS LEG BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-05-25 |
| K945204 | URINE COLLECTOR & ACCESSORIES | Nelmed Corp. | 1994-11-02 |
| K934052 | ALPINE REUSABLE LEG BAGS | Sierra Laboratories, Inc. | 1994-01-07 |
| K931727 | URINARY DRAINAGE BAG CADDY | Neotech Products, Inc. | 1993-07-23 |
| K926035 | BARD LEG BAG HOLDER | C.R. Bard, Inc. | 1992-12-17 |
| K924406 | CONVEEN(R) LEG BAG(500 ML) | Coloplast A/S | 1992-10-30 |
| K903611 | ILC LEG BAG HOLDER | Inman Liebelt Corp. | 1990-10-26 |
| K901219 | EXTERNAL LEG BAG | Orion Life Systems, Inc. | 1990-06-27 |
| K896129 | URINARY LEG BAG | Cypress Medical Products, Ltd. | 1990-04-16 |
| K896728 | 4 SURE URINARY LEG BAG | The Boston & Pacific Co., Inc. | 1990-02-20 |
| K780190 | CATHETER STRAP & RUINARY BAY HOLDER | Baka Manufacturing Co., Inc. | 1978-02-21 |
| K772402 | QUADRIPLEGIC URINARY DRAINAGE VALVE | Fred Sammons, Inc. | 1978-01-26 |
| K780032 | URINARY LEG BAG | C.R. Bard, Inc. | 1978-01-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10192253028645 | Dover | Cardinal Health 200, LLC | 2025-04-04 |
| 10192253028652 | Dover | Cardinal Health 200, LLC | 2025-04-04 |
| 10192253028669 | Dover | Cardinal Health 200, LLC | 2025-04-04 |
| 10850053289207 | SURGYCO | Surgyco LLC | 2023-12-15 |
| 10850053289214 | SURGYCO | Surgyco LLC | 2023-12-15 |
| 10850053289221 | SURGYCO | Surgyco LLC | 2023-12-15 |
| 10810087350496 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| 10885632100802 | MediChoice | OWENS & MINOR DISTRIBUTION, INC. | 2020-08-27 |
| 10885380126376 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-07-19 |
| 10885380126369 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-07-19 |
| 10885380126352 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-07-19 |
| 10885380126345 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-07-19 |
| 10885380126338 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-07-19 |
| 10885380126383 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-07-19 |
| 10885380126390 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-07-19 |
| 10885380126406 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-07-19 |
| 10704411008286 | AMSure® Urinary Leg Bag | AMSINO INTERNATIONAL, INC. | 2018-05-30 |
| 10704411008309 | AMSure® Urinary Leg Bag | AMSINO INTERNATIONAL, INC. | 2018-05-30 |
| 10704411008279 | AMSure® Urinary Leg Bag | AMSINO INTERNATIONAL, INC. | 2018-05-30 |
| 10704411008262 | AMSure® Urinary Leg Bag | AMSINO INTERNATIONAL, INC. | 2018-05-30 |
| 10704411008255 | AMSure® Urinary Leg Bag | AMSINO INTERNATIONAL, INC. | 2018-05-30 |
| 10704411008248 | AMSure® Urinary Leg Bag | AMSINO INTERNATIONAL, INC. | 2018-05-30 |
| 10704411008231 | AMSure® Urinary Leg Bag | AMSINO INTERNATIONAL, INC. | 2018-05-30 |
| 10704411006282 | AMSure® Urinary Leg Bag with Extension Tube | AMSINO INTERNATIONAL, INC. | 2017-07-01 |
| 10704411006268 | AMSure® Urinary Leg Bag with Extension Tube | AMSINO INTERNATIONAL, INC. | 2017-07-01 |
| 10704411006251 | AMSure® Urinary Leg Bag with Extension Tube | AMSINO INTERNATIONAL, INC. | 2017-07-01 |
| 10080196836062 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196990337 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196990320 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196839193 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |