The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Repositionable Clip.
| Device ID | K123601 |
| 510k Number | K123601 |
| Device Name: | SINGLE USE REPOSITIONABLE CLIP |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170385947 | K123601 | 000 |
| 14953170385930 | K123601 | 000 |
| 14953170385923 | K123601 | 000 |
| 14953170385916 | K123601 | 000 |
| 14953170345200 | K123601 | 000 |
| 14953170345187 | K123601 | 000 |
| 14953170345163 | K123601 | 000 |
| 14953170345149 | K123601 | 000 |