K942338 is an FDA 510(k) clearance for the OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES, a Duodenoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FDT), submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on November 30, 1994, 198 days after receiving the submission on May 16, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K942338 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 16, 1994 |
| Decision Date | November 30, 1994 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDT — Duodenoscope And Accessories, Flexible/rigid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine The Duodenum And To Perform Various Procedures Within The Duodenum. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |