Top Gun
FDA 510(k) K933742 · Bio-Medical Devices, Inc.
510(k) numberK933742
Submission
- Device name
- Top Gun
- Applicant
- Bio-Medical Devices, Inc.
Irvine, CA, US - Received
- August 3, 1993
- Decision date
- April 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FQH – Lavage, Jet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5475
- Specialty
- General Hospital
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| K253996 | BD Surgiphor Antimicrobial Irrigation System (910110)FQH · Special | Becton, Dickinson and Company (BD) | 02/25/2026SE |
| K253445 | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)FQH · Traditional | Bd | 02/20/2026SE |
| K231023 | ERBEJET® 2 SystemFQH · Traditional | Erbe Elektromedizin GmbH | 06/15/2023SE |
| K220759 | Armis VeriCyn Wound WashFQH · Traditional | Armis Biopharma, Inc. | 05/25/2023SE |
| K220964 | VERSAJET Hydrosurgery System (III)FQH · Traditional | Smith & Nephew Medical Limited | 05/16/2023SE |
| K221504 | BD Surgiphor Antimicrobial Irrigation SystemFQH · Traditional | Bd | 10/14/2022SE |
| K222804 | Irrisept Antimicrobial Wound LavageFQH · Special | Irrimax Corporation | 09/22/2022SE |
| K210987 | IRRIGO Wound Wash Jet SystemFQH · Traditional | Inopro, Inc. | 05/31/2022SE |
| K213616 | BD Surgiphor Antimicrobial Irrigation SystemFQH · Traditional | Becton, Dickinson and Company | 03/23/2022SE |
| K210536 | Irrisept Antimicrobial Wound LavageFQH · Traditional | Irrimax Corporation | 05/28/2021SE |
More from Irrimax Corporation
| 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 |
| K955149 | Maxi-Flow Suction Handle/The Reel Thing Tubing ReelBYY · Traditional | 01/24/1996SE |
| K955150 | Maxi-FlowBYY · Traditional | 01/23/1996SE |
| K940156 | The Reel ThingGBX · Traditional | 06/07/1994SE |
Questions and answers
When was Top Gun cleared by the FDA?
Top Gun (K933742) received a 510(k) decision of Substantially Equivalent on April 7, 1994, 247 days after the submission was received.
What is the product code of K933742?
The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.