Amp Closed Urinary Drainage Bag, 1011 & 1011N
FDA 510(k) K861251 · American Medical Products, Inc.
510(k) numberK861251
Submission
- Device name
- Amp Closed Urinary Drainage Bag, 1011 & 1011N
- Applicant
- American Medical Products, Inc.
Jacksonville, FL, US - Received
- April 2, 1986
- Decision date
- April 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110518 | IbagKNX · Traditional | Future Path Medical, LLC | 06/24/2011SE |
| K973364 | 4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage BagKNX · Traditional | Maersk Medical A/S | 03/17/1998SE |
| K972887 | Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg BagKNX · Traditional | Medline Industries, Inc. | 12/11/1997SE |
| K971271 | Besecure External Urinary Collection SystemKNX · Traditional | Urology Research Intl., Inc. | 08/18/1997SE |
| K971929 | Amsino Urinary Leg BagKNX · Traditional | Amsino Intl., Inc. | 08/06/1997SE |
| K971764 | Welcon Hue-Vu Urinary Drainage BagKNX · Traditional | Welcon, Inc. | 07/29/1997SE |
| K964690 | Liberty ValveKNX · Traditional | Cleveland Medical Devices, Inc. | 03/21/1997SE |
| K964745 | Amsino Urinary Drainage BagKNX · Traditional | Amsino Intl., Inc. | 03/18/1997SE |
| K962652 | Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)KNX · Traditional | Customed, Inc. | 10/04/1996SE |
| K960949 | Prosys Bedside Drainage Bag (Sterile) Model 650167KNX · Traditional | Bristol-Myers Squibb | 04/19/1996SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K922290 | Single-Step Pregnancy, HCG TestJHI · Traditional | 07/09/1992SE |
| K862221 | E-Z CleanGEI · Traditional | 09/12/1986SE |
| K830881 | Ampercide Disinfectant Accessory to -FKX · Traditional | 06/02/1983SE |
| K823827 | Amp 80/2 Outflow Monitor ModificationFKX · Traditional | 03/17/1983SE |
| K822551 | Amp Capd Unispike Aministration SetFKK · Traditional | 10/13/1982SE |
| K822550 | Safe Lock Titanium Adapter SetFKX · Traditional | 10/13/1982SE |
| K822549 | CCPD Cycler Set W/5 Pronged Safe LockFKX · Traditional | 10/13/1982SE |
| K822548 | Safe Lock Catheter S-3FKX · Traditional | 10/13/1982SE |
| K822546 | Safe Lock Sealing CapsFKX · Traditional | 10/13/1982SE |
| K822545 | CCPD Cycler Set W/5 Pronged ConnectorFKX · Traditional | 10/13/1982SE |
Questions and answers
When was Amp Closed Urinary Drainage Bag, 1011 & 1011N cleared by the FDA?
Amp Closed Urinary Drainage Bag, 1011 & 1011N (K861251) received a 510(k) decision of Substantially Equivalent on April 17, 1986, 15 days after the submission was received.
What is the product code of K861251?
The FDA product code is KNX – Collector, Urine, (And Accessories) For Indwelling Catheter, a Class II (moderate risk) device regulated under 21 CFR 876.5250.