Tribag, Urine Bag System #1109,& 1301-12
FDA 510(k) K802012 · Pollak (Intl.), Ltd.
510(k) numberK802012
Submission
- Device name
- Tribag, Urine Bag System #1109,& 1301-12
- Applicant
- Pollak (Intl.), Ltd.
Mchenry, IL, US - Received
- August 20, 1980
- Decision date
- September 9, 1980
- 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 |
More from Bristol-Myers Squibb
| 510(k) | Device | Decision |
|---|---|---|
| K000227 | UmbicutHFW · Traditional | 04/27/2000SE |
| K810049 | Pedicat*KMJ · Traditional | 04/21/1981SE |
| K810050 | Vecafix*KGX · Traditional | 03/26/1981SE |
| K802011 | Infussion Alarm System I.A.S. CAT.#1118FLN · Traditional | 10/31/1980SE |
| K802009 | Flowclamp CAT.#1011 & 1012FKK · Traditional | 10/31/1980SE |
| K802017 | Dressing Change Set CAT.#910-930KDD · Traditional | 10/10/1980SE |
| K802007 | Pediwet=Guaze Impregnated with PetrolFRQ · Traditional | 09/26/1980SE |
| K802022 | Sterile Guaze Swabs CAT.#301-420EFQ · Traditional | 09/16/1980SE |
| K802021 | Pediband CAT.#195-197NAD · Traditional | 09/16/1980SE |
| K802019 | Suture Removal Set CAT.#906KDD · Traditional | 09/16/1980SE |
Questions and answers
When was Tribag, Urine Bag System #1109,& 1301-12 cleared by the FDA?
Tribag, Urine Bag System #1109,& 1301-12 (K802012) received a 510(k) decision of Substantially Equivalent on September 9, 1980, 20 days after the submission was received.
What is the product code of K802012?
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.