Alpine Reusable Leg Bags
FDA 510(k) K934052 · Sierra Laboratories, Inc.
510(k) numberK934052
Submission
- Device name
- Alpine Reusable Leg Bags
- Applicant
- Sierra Laboratories, Inc.
Tucson, AZ, US - Received
- August 19, 1993
- Decision date
- January 7, 1994
- 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 |
| 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 |
More from Coloplast A/S
| 510(k) | Device | Decision |
|---|---|---|
| K970966 | Comfort Cath Choice Male External CatheterEXJ · Traditional | 04/22/1997SE |
| K962413 | Comfort Cath Special Self Adhering Male External CatheterEXJ · Traditional | 07/15/1996SE |
| K962384 | Comfort Sheath Reusable Male External CatheterEXJ · Traditional | 07/15/1996SE |
| K934266 | Comfort Cath Self Adhering Male External CatheterEXJ · Traditional | 04/19/1994SE |
| K931156 | Cone CathEXJ · Traditional | 07/01/1993SE |
| K901000 | Uro Tex UrinalsEYZ · Traditional | 03/26/1990SE |
| K883057 | Comfort Cath Male External CatheterEYT · Traditional | 08/02/1988SE |
| K873039 | Model 820 Top=TrakBYN · Traditional | 02/11/1988SE |
| K832450 | Uro-Tex Male External CatheterKNX · Traditional | 10/14/1983SE |
| K811887 | Skin Staple ExtractorKBC · Traditional | 07/27/1981SE |
Questions and answers
When was Alpine Reusable Leg Bags cleared by the FDA?
Alpine Reusable Leg Bags (K934052) received a 510(k) decision of Substantially Equivalent on January 7, 1994, 141 days after the submission was received.
What is the product code of K934052?
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.