K885220 is an FDA 510(k) clearance for the PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Ethox Corp. (Buffalo, US). The FDA issued a Cleared decision on September 25, 1989, 279 days after receiving the submission on December 20, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K885220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | December 20, 1988 |
| Decision Date | September 25, 1989 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |