K984168 is an FDA 510(k) clearance for the BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE. This device is classified as a Instrument, Biopsy, Mechanical, Gastrointestinal (Class II - Special Controls, product code FCF).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on December 7, 1999, 382 days after receiving the submission on November 20, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K984168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 1998 |
| Decision Date | December 07, 1999 |
| Days to Decision | 382 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCF — Instrument, Biopsy, Mechanical, Gastrointestinal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |