Curity Irrigation Tray
FDA 510(k) K771079 · Kendall Research Center
510(k) numberK771079
Submission
- Device name
- Curity Irrigation Tray
- Applicant
- Kendall Research Center
Mchenry, IL, US - Received
- June 15, 1977
- Decision date
- September 15, 1977
- 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 |
|---|---|---|
| K802225 | Tender-Sorb Drain SpongesNAB · Traditional | 09/26/1980SE |
| K781357 | T.E.D. Sequential Compression SleevesJOW · Traditional | 09/20/1978SE |
| K780408 | Micronet Light Dressing SpongeNAB · Traditional | 03/22/1978SE |
| K780062 | Catheter/Hemostatic/GeriatricEZL · Traditional | 02/14/1978SE |
| K780120 | Anesthesia Tray, CaudalCAZ · Traditional | 02/06/1978SE |
| K772134 | Syringe, Irrigation, Pre-FilledKOA · Traditional | 11/28/1977SE |
| K772133 | Urine Specimen Collecting DeviceFCN · Traditional | 11/28/1977SE |
| K771655 | Curity PeakometerFFG · Traditional | 10/14/1977SE |
| K771563 | Conform Elastic NettingFQM · Traditional | 09/12/1977SE |
| K771452 | Conform Stretch Bandage (5SIZES)ITG · Traditional | 09/12/1977SE |
Questions and answers
When was Curity Irrigation Tray cleared by the FDA?
Curity Irrigation Tray (K771079) received a 510(k) decision of Substantially Equivalent on September 15, 1977, 92 days after the submission was received.
What is the product code of K771079?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.