The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Small Intestinal Videoscope System.
| Device ID | K071254 |
| 510k Number | K071254 |
| Device Name: | SMALL INTESTINAL VIDEOSCOPE SYSTEM |
| Classification | Enteroscope And Accessories |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FDA |
| Subsequent Product Code | FED |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-04 |
| Decision Date | 2008-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170339943 | K071254 | 000 |
| 14953170237208 | K071254 | 000 |
| 04953170237423 | K071254 | 000 |
| 04953170237461 | K071254 | 000 |
| 04953170239533 | K071254 | 000 |
| 04953170239564 | K071254 | 000 |
| 04953170239571 | K071254 | 000 |
| 04953170239588 | K071254 | 000 |
| 04953170239595 | K071254 | 000 |
| 04953170242526 | K071254 | 000 |
| 04953170281082 | K071254 | 000 |
| 04953170339936 | K071254 | 000 |
| 04953170022852 | K071254 | 000 |