Conveen Urine Bag - Sterile
FDA 510(k) K955609 · Coloplast Corp.
510(k) numberK955609
Submission
- Device name
- Conveen Urine Bag - Sterile
- Applicant
- Coloplast Corp.
Marietta, GA, US - Received
- December 8, 1995
- Decision date
- December 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FAQ – Bag, Urine Collection, Leg, For External Use, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FAQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962604 | Prosys Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient SizingFAQ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 07/18/1996SE |
| K960217 | CPR Urine BagFAQ · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K953767 | Prosys Bedside Drainage BagFAQ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 12/20/1995SE |
| K953783 | Conveen Leg Bag StrapFAQ · Traditional | Coloplast Corp. | 09/13/1995SE |
| K951945 | Prosys Leg BagFAQ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 05/25/1995SE |
| K945204 | Urine Collector & AccessoriesFAQ · Traditional | Nelmed Corp. | 11/02/1994SE |
| K934052 | Alpine Reusable Leg BagsFAQ · Traditional | Sierra Laboratories, Inc. | 01/07/1994SE |
| K931727 | Urinary Drainage Bag CaddyFAQ · Traditional | Neotech Products, Inc. | 07/23/1993SE |
| K926035 | Bard Leg Bag HolderFAQ · Traditional | C.R. Bard, Inc. | 12/17/1992SE |
| K924406 | Conveen(R) Leg BAG(500 ML)FAQ · Traditional | Coloplast A/S | 10/30/1992SE |
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Questions and answers
When was Conveen Urine Bag - Sterile cleared by the FDA?
Conveen Urine Bag - Sterile (K955609) received a 510(k) decision of Substantially Equivalent on December 29, 1995, 21 days after the submission was received.
What is the product code of K955609?
The FDA product code is FAQ – Bag, Urine Collection, Leg, For External Use, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.