Urinary Drainage Bag Caddy
FDA 510(k) K931727 · Neotech Products, Inc.
510(k) numberK931727
Submission
- Device name
- Urinary Drainage Bag Caddy
- Applicant
- Neotech Products, Inc.
Chatsworth, CA, US - Received
- March 3, 1993
- Decision date
- July 23, 1993
- 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 |
| K955609 | Conveen Urine Bag - SterileFAQ · Traditional | Coloplast Corp. | 12/29/1995SE |
| 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 |
| 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 |
More from Coloplast A/S
| 510(k) | Device | Decision |
|---|---|---|
| K011564 | NeoleadDRX · Traditional | 01/03/2002SE |
| K921024 | Uro-Tote Leg BagKNX · Traditional | 09/02/1992SE |
| K890425 | Neotech Mucus Trap W/CatheterBSY · Traditional | 04/19/1989SE |
| K882203 | Neotech Universal AdapterBZA · Traditional | 06/17/1988SE |
| K880487 | Neotech Meconium Aspirator (Sterile)BTR · Traditional | 05/06/1988SE |
Questions and answers
When was Urinary Drainage Bag Caddy cleared by the FDA?
Urinary Drainage Bag Caddy (K931727) received a 510(k) decision of Substantially Equivalent on July 23, 1993, 142 days after the submission was received.
What is the product code of K931727?
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.