The following data is part of a premarket notification filed by Olympus Opto-electronics Co., Ltd. with the FDA for Xsif-1tq140a Small Intestinal Videoscope.
| Device ID | K031256 |
| 510k Number | K031256 |
| Device Name: | XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE |
| Classification | Enteroscope And Accessories |
| 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 | FDA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-21 |
| Decision Date | 2003-07-23 |
| Summary: | summary |