MMG External Female Catheters
FDA 510(k) K854821 · Medical Technologies of Georgia
510(k) numberK854821
Submission
- Device name
- MMG External Female Catheters
- Applicant
- Medical Technologies of Georgia
Wilbraham, MA, US - Received
- December 3, 1985
- Decision date
- April 24, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K080878 | MTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe (with and Without Kit)KOD · Traditional | 07/17/2008SE |
| K973120 | Readycath CatheterGBM · Traditional | 02/25/1998SE |
| K952392 | Mli SetFPA · Traditional | 08/07/1995SE |
| K911129 | MMG Bile BagEXF · Traditional | 08/07/1991SE |
| K873136 | MMG Cath-N-PlaceKNX · Traditional | 09/09/1987SE |
| K871949 | MMG Delee Suction Catheter W/Mucous TrapBSY · Traditional | 06/15/1987SE |
| K854660 | The MMG Enteral Feeding Administration SetKNT · Traditional | 01/21/1986SE |
| K840839 | MMG Foley CatheterKOD · Traditional | 04/17/1984SE |
| K840897 | Oxygen TubingCAT · Traditional | 03/16/1984SE |
| K821854 | U-200 BagKNX · Traditional | 07/22/1982SE |
Questions and answers
When was MMG External Female Catheters cleared by the FDA?
MMG External Female Catheters (K854821) received a 510(k) decision of Substantially Equivalent on April 24, 1986, 142 days after the submission was received.
What is the product code of K854821?
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.