Maxi-Flow Suction Handle/The Reel Thing Tubing Reel
FDA 510(k) K955149 · Bio-Medical Devices, Inc.
510(k) numberK955149
Submission
- Device name
- Maxi-Flow Suction Handle/The Reel Thing Tubing Reel
- Applicant
- Bio-Medical Devices, Inc.
Irvine, CA, US - Received
- November 13, 1995
- Decision date
- January 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BYY – Tube, Aspirating, Flexible, Connecting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code BYY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960616 | Vitaflow Suction/Aspiration Tubing SetBYY · Traditional | Vital Concepts, Inc. | 05/06/1996SE |
| K960218 | Connecting TubingBYY · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K955151 | Maxi-Flow Suction Tube/Top Gun Suction IrrigatorBYY · Traditional | Bio-Medical Devices, Inc. | 01/24/1996SE |
| K955150 | Maxi-FlowBYY · Traditional | Bio-Medical Devices, Inc. | 01/23/1996SE |
| K922989 | Wiltek Irrigaiton/Aspiration Tube SetBYY · Traditional | Wiltek Medical, Inc. | 02/15/1994SE |
| K911586 | General Hospital Tubing Clamp (Non-Electric)BYY · Traditional | Megadyne Medical Products, Inc. | 07/02/1991SE |
| K901761 | Sterile Suction Tubing SetBYY · Traditional | Acacia Laboratories, Inc. | 05/07/1990SE |
| K873463 | Van Dellen Aspirating TubingBYY · Traditional | Van Dellen, Ltd. | 11/23/1987SE |
| K853296 | Emodren Guide Needle for Drainage Tube & EmodrenBYY · Traditional | Parexel Intl. Corp. | 08/15/1985SE |
| K843470 | Pharma-Plast Connecting Tube Type Suct-BYY · Traditional | Zimmar Consulting , Ltd. | 11/16/1984SE |
More from Zimmar Consulting , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K040485 | Maxair Surgical Helmet SystemFYA · Traditional | 10/18/2004SE |
| K981888 | Smoke-EvacGEI · Traditional | 10/15/1998SE |
| K955151 | Maxi-Flow Suction Tube/Top Gun Suction IrrigatorBYY · Traditional | 01/24/1996SE |
| K955150 | Maxi-FlowBYY · Traditional | 01/23/1996SE |
| K940156 | The Reel ThingGBX · Traditional | 06/07/1994SE |
| K933742 | Top GunFQH · Traditional | 04/07/1994SE |
Questions and answers
When was Maxi-Flow Suction Handle/The Reel Thing Tubing Reel cleared by the FDA?
Maxi-Flow Suction Handle/The Reel Thing Tubing Reel (K955149) received a 510(k) decision of Substantially Equivalent on January 24, 1996, 72 days after the submission was received.
What is the product code of K955149?
The FDA product code is BYY – Tube, Aspirating, Flexible, Connecting, a Class II (moderate risk) device regulated under 21 CFR 880.6740.