The following data is part of a premarket notification filed by Olympus Opto-electronics Co., Ltd. with the FDA for Gastrointestinal Videoscope Xgif-q14om, Xgif-2t140m Colonovideoscope Xcf-q14ml/i, Xpcf-160aml/i.
| Device ID | K032177 |
| 510k Number | K032177 |
| Device Name: | GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS OPTO-ELECTRONICS CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Tina Steffanie-oak |
| Correspondent | Tina Steffanie-oak OLYMPUS OPTO-ELECTRONICS CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-16 |
| Decision Date | 2003-10-02 |
| Summary: | summary |