The following data is part of a premarket notification filed by Flexible Stenting Solutions, Inc. with the FDA for Flexstent Biliary Self-expanding Stent System.
| Device ID | K121125 |
| 510k Number | K121125 |
| Device Name: | FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | FLEXIBLE STENTING SOLUTIONS, INC. 23 Christopher Way, Suite 103 Eatontown, NJ 07724 |
| Contact | Joseph C Griffin Iii |
| Correspondent | Joseph C Griffin Iii FLEXIBLE STENTING SOLUTIONS, INC. 23 Christopher Way, Suite 103 Eatontown, NJ 07724 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-13 |
| Decision Date | 2012-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032066348 | K121125 | 000 |
| 20705032065747 | K121125 | 000 |
| 20705032065730 | K121125 | 000 |
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| 20705032066188 | K121125 | 000 |
| 20705032066096 | K121125 | 000 |
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| 20705032065914 | K121125 | 000 |
| 20705032065907 | K121125 | 000 |
| 20705032065662 | K121125 | 000 |