FDA Product Code
FDA Product Code FAQ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5250
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Traditional | PDF ↗ |
| K960217 | CPR URINE BAG | Custom Pack Reliability | 1996-03-28 | Traditional | PDF ↗ |
| K955609 | CONVEEN URINE BAG - STERILE | Coloplast Corp. | 1995-12-29 | Traditional | PDF ↗ |
| K953767 | PROSYS BEDSIDE DRAINAGE BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-12-20 | Traditional | PDF ↗ |
| K953783 | CONVEEN LEG BAG STRAP | Coloplast Corp. | 1995-09-13 | Traditional | PDF ↗ |
| K951945 | PROSYS LEG BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-05-25 | Traditional | PDF ↗ |
| K945204 | URINE COLLECTOR & ACCESSORIES | Nelmed Corp. | 1994-11-02 | Traditional | PDF ↗ |
| K934052 | ALPINE REUSABLE LEG BAGS | Sierra Laboratories, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K931727 | URINARY DRAINAGE BAG CADDY | Neotech Products, Inc. | 1993-07-23 | Traditional | PDF ↗ |
| K926035 | BARD LEG BAG HOLDER | C.R. Bard, Inc. | 1992-12-17 | Traditional | PDF ↗ |
| K924406 | CONVEEN(R) LEG BAG(500 ML) | Coloplast A/S | 1992-10-30 | Traditional | PDF ↗ |
| K903611 | ILC LEG BAG HOLDER | Inman Liebelt Corp. | 1990-10-26 | Traditional | PDF ↗ |
| K901219 | EXTERNAL LEG BAG | Orion Life Systems, Inc. | 1990-06-27 | Traditional | PDF ↗ |
| K896129 | URINARY LEG BAG | Cypress Medical Products, Ltd. | 1990-04-16 | Traditional | PDF ↗ |
| K896728 | 4 SURE URINARY LEG BAG | The Boston & Pacific Co., Inc. | 1990-02-20 | Traditional | PDF ↗ |
| K780190 | CATHETER STRAP & RUINARY BAY HOLDER | Baka Manufacturing Co., Inc. | 1978-02-21 | Traditional | PDF ↗ |
| K772402 | QUADRIPLEGIC URINARY DRAINAGE VALVE | Fred Sammons, Inc. | 1978-01-26 | Traditional | PDF ↗ |
| K780032 | URINARY LEG BAG | C.R. Bard, Inc. | 1978-01-17 | Traditional | PDF ↗ |
Product code FAQ · Class I · Gastroenterology, Urology. Data: openFDA.