Gesco Catheterization Tray
FDA 510(k) K882647 · Gesco Intl., Inc.
510(k) numberK882647
Submission
- Device name
- Gesco Catheterization Tray
- Applicant
- Gesco Intl., Inc.
San Antonio, TX, US - Received
- June 27, 1988
- Decision date
- September 9, 1988
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBQ – Catheter, Continuous Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941356 | Microflow Irrigation SystemGBQ · Traditional | Jedmed Instrument Co. | 05/19/1994SE |
| K921464 | CAT.#40100, 40102, 40104 & 40106 Yankauer Suct IntGBQ · Traditional | Trinity Laboratories, Inc. | 05/05/1992SE |
| K874596 | Perforated Soaking TubeGBQ · Traditional | Specialty Medical Products Co. | 12/02/1987SE |
| K873097 | Procedual Changes/Assembly Process for Plus PaksGBQ · Traditional | Ipax, Inc. | 09/04/1987SE |
| K872787 | Modified CurlcathGBQ · Traditional | Quinton, Inc. | 08/04/1987SE |
| K791400 | Gastric Lavage Kit-DisposableGBQ · Traditional | Acumed Instruments Corp. | 08/16/1979SE |
| K771732 | Thornton Anterior Chamber IrrigatorGBQ · Traditional | Concept, Inc. | 09/28/1977SE |
More from Concept, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954422 | Per-Q-Cath Mid-LineLJS · Traditional | 12/15/1995SE |
| K940953 | Umbili-Cath-SFOS · Traditional | 08/02/1994SE |
| K940870 | Umbili-CathFOS · Traditional | 08/02/1994SE |
| K940952 | Umbili-Cath-S-DlFOS · Traditional | 07/29/1994SE |
| K941672 | Uri-Cath CatheterGBM · Traditional | 05/16/1994SE |
| K941232 | Thora-CathJOL · Traditional | 05/11/1994SE |
| K940871 | Umbili-Cath-PFOS · Traditional | 04/29/1994SE |
| K931989 | Ventri-CathJXG · Traditional | 07/21/1993SE |
| K926063 | Per-Q-Cath Dressing Change TrayMCY · Traditional | 06/07/1993SEKD |
| K923591 | Pala-NateBTR · Traditional | 03/16/1993SE |
Questions and answers
When was Gesco Catheterization Tray cleared by the FDA?
Gesco Catheterization Tray (K882647) received a 510(k) decision of Unknown on September 9, 1988, 74 days after the submission was received.
What is the product code of K882647?
The FDA product code is GBQ – Catheter, Continuous Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.