The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Systems Integration Endoalpha Medical Control Unit For Endosurgery Uces-4 Software Version 1.
| Device ID | K172618 |
| 510k Number | K172618 |
| Device Name: | SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Sheri L. Musgnung Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-31 |
| Decision Date | 2017-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170391965 | K172618 | 000 |
| 04953170391903 | K172618 | 000 |
| 04953170391873 | K172618 | 000 |
| 04953170391842 | K172618 | 000 |
| 04953170391804 | K172618 | 000 |
| 04953170391767 | K172618 | 000 |
| 04953170406461 | K172618 | 000 |