K863635 is an FDA 510(k) clearance for the UPDATED STERILE ENDOTRACHEAL BRUSHES. This device is classified as a Brush, Cleaning, Tracheal Tube (Class I - General Controls, product code EPE).
Submitted by Biological & Environmental Control Laboratories (Toledo, US). The FDA issued a Cleared decision on November 3, 1986, 47 days after receiving the submission on September 17, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5795.
| 510(k) Number | K863635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1986 |
| Decision Date | November 03, 1986 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | EPE — Brush, Cleaning, Tracheal Tube |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5795 |