K983220 is an FDA 510(k) clearance for the STRYKER INFRAVISION ESOPHAGEAL KIT. This device is classified as a Bougie, Esophageal, And Gastrointestinal, Gastro-urology (Class II - Special Controls, product code FAT).
Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on June 4, 1999, 263 days after receiving the submission on September 14, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K983220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1998 |
| Decision Date | June 04, 1999 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAT — Bougie, Esophageal, And Gastrointestinal, Gastro-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5365 |