Drainage Tube Restraint/Wound Cover
FDA 510(k) K905766 · M. Imonti and Associates Inc.,
510(k) numberK905766
Submission
- Device name
- Drainage Tube Restraint/Wound Cover
- Applicant
- M. Imonti and Associates Inc.,
San Juan Capistrano, CA, US - Received
- December 27, 1990
- Decision date
- March 6, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131659 | Moerae Vein Preparation KitGBX · Traditional | Moerae Matrix, Inc. | 03/03/2014SE |
| K082725 | Graftguard Pressure Controlling SyringeGBX · Traditional | Maquet Cardiovascular, LLC | 12/17/2008SE |
| K052286 | Deutsch Anti-Blockage Wound DrainGBX · Traditional | The Catheter Exchange, Inc. | 10/21/2005SE |
| K043515 | GraftsaverGBX · Traditional | Vescare, Inc. | 03/31/2005SE |
| K013417 | Misonix Irrigation System Moedl BC20PGBX · Traditional | Misonix, Inc. | 01/10/2002SE |
| K000704 | DMC Saphenous Vein Distention System (SVDS)GBX · Traditional | Dmc Medical, Ltd. | 05/19/2000SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional | Allegiance Healthcare Corp. | 12/04/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | Ultracell Medical Technologies, Inc. | 10/01/1997SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | Axiom Medical, Inc. | 03/10/1997SE |
More from Axiom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950800 | Pro-Pak for Oms DiplomateHQC · Traditional | 05/22/1995SE |
| K950799 | Pro-VitHQE · Traditional | 04/28/1995SE |
| K933627 | Phacofragmentor TipHQC · Traditional | 01/25/1994SE |
| K933503 | Pro-Phaco HandpieceHQC · Traditional | 01/06/1994SE |
| K924551 | Endo Trachea Tube FixationCBH · Traditional | 12/08/1992SE |
Questions and answers
When was Drainage Tube Restraint/Wound Cover cleared by the FDA?
Drainage Tube Restraint/Wound Cover (K905766) received a 510(k) decision of Substantially Equivalent on March 6, 1991, 69 days after the submission was received.
What is the product code of K905766?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.