Tracheostomy Cleansing Solution
FDA 510(k) K862563 · Clinipad Corp.
510(k) numberK862563
Submission
- Device name
- Tracheostomy Cleansing Solution
- Applicant
- Clinipad Corp.
Guilford, CT, US - Received
- July 3, 1986
- Decision date
- July 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EPE – Brush, Cleaning, Tracheal Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5795
- Specialty
- Anesthesiology
Other 510(k)s with product code EPE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K863635 | Updated Sterile Endotracheal BrushesEPE · Traditional | Biological & Environmental Control Laboratories | 11/03/1986SE |
More from Biological & Environmental Control Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K931560 | Cardiac Catheterization TrayDQO · Traditional | 07/11/1994SEKD |
| K931668 | Picc Insertion TrayFOZ · Traditional | 03/07/1994SEKD |
| K932071 | I.V. Start KitFOZ · Traditional | 02/17/1994SEKD |
| K932010 | V.A.D. Access KitLJT · Traditional | 02/03/1994SE |
| K932036 | Laceration TrayFRG · Traditional | 12/13/1993SESK |
| K932016 | Tracheostomy Care TrayJOH · Traditional | 11/03/1993SE |
| K862562 | Punch Biopsy KitKNW · Traditional | 10/07/1986SE |
| K833075 | Wet Dressing KitKDD · Traditional | 01/27/1984SE |
| K833432 | Catheter Insertion KitKOD · Traditional | 12/28/1983SE |
| K830476 | Or Prep KitFRG · Traditional | 03/31/1983SE |
Questions and answers
When was Tracheostomy Cleansing Solution cleared by the FDA?
Tracheostomy Cleansing Solution (K862563) received a 510(k) decision of Substantially Equivalent on July 15, 1986, 12 days after the submission was received.
What is the product code of K862563?
The FDA product code is EPE – Brush, Cleaning, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5795.