Aspri-Luke
FDA 510(k) K791847 · Medical Marketing Group
510(k) numberK791847
Submission
- Device name
- Aspri-Luke
- Applicant
- Medical Marketing Group
Decatur, GA, US - Received
- September 19, 1979
- Decision date
- October 2, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYZ – Trap, Sterile Specimen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code BYZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925412 | Electromedics Tissue Trap/ #TT280BYZ · Traditional | Electromedics, Inc. | 02/05/1993SE |
| K913643 | Mucous Specimen TrapBYZ · Traditional | Medical Device Inspection Co., Inc. | 10/10/1991SE |
| K902883 | Tissue/Polyp Trap SystemBYZ · Traditional | Triton Technology, Inc. | 09/12/1990SE |
| K841409 | Bush Neck W/PlugBYZ · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
| K840253 | One-Way Air ValveBYZ · Traditional | Delta Medical Industries | 04/05/1984SE |
| K834467 | Specimen TrapBYZ · Traditional | Microvasive | 02/17/1984SE |
| K822557 | Specimen AdaptorBYZ · Traditional | Bemis Health Care | 10/18/1982SE |
| K822556 | Critical Measurement UnitBYZ · Traditional | Bemis Health Care | 10/18/1982SE |
More from Bemis Health Care
| 510(k) | Device | Decision |
|---|---|---|
| K910022 | Mmg/O'Neil Urinary Catheterization System KitFCM · Traditional | 04/02/1991SEKD |
| K884819 | O'Neil Urinary Catheter IntroducerKNY · Traditional | 02/17/1989SE |
| K874682 | MMG Catheter Plug W/Drainage Tube CoverKOD · Traditional | 01/27/1988SE |
| K871999 | MMG Uro-Self CatheterGBM · Traditional | 08/25/1987SE |
| K863912 | The MMG 5 in 1 ConnectorBYX · Traditional | 10/27/1986SE |
| K840838 | MMG Connective TubingGAZ · Traditional | 03/30/1984SE |
| K821168 | Disposable Urinary Legbag W/StrapKNX · Traditional | 05/24/1982SE |
| K811469 | MMG Urinary Drainage TubingKNX · Traditional | 06/12/1981SE |
| K800694 | MMG Disposable Urinary Leg BagKNX · Traditional | 05/30/1980SE |
| K790279 | Catheter, MMG Latex ExternalKNX · Traditional | 03/06/1979SE |
Questions and answers
When was Aspri-Luke cleared by the FDA?
Aspri-Luke (K791847) received a 510(k) decision of Substantially Equivalent on October 2, 1979, 13 days after the submission was received.
What is the product code of K791847?
The FDA product code is BYZ – Trap, Sterile Specimen, a Class II (moderate risk) device regulated under 21 CFR 880.6740.