K071579 is an FDA 510(k) clearance for the PEF TUBE. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT).
Submitted by N.M. Beale Co., Inc. (Ayer, US). The FDA issued a Cleared decision on November 20, 2007, 165 days after receiving the submission on June 8, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K071579 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 08, 2007 |
| Decision Date | November 20, 2007 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |