The following data is part of a premarket notification filed by Ovesco Endoscopy Ag with the FDA for Otsc (over-the Scope-clip) System Set.
| Device ID | K101428 |
| 510k Number | K101428 |
| Device Name: | OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | OVESCO ENDOSCOPY AG KASTELLSTR. 8 BADEN WUERTTEMBERG Karlsruhe, DE 76227 |
| Contact | Arne Briest |
| Correspondent | Arne Briest OVESCO ENDOSCOPY AG KASTELLSTR. 8 BADEN WUERTTEMBERG Karlsruhe, DE 76227 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-21 |
| Decision Date | 2010-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260206311119 | K101428 | 000 |
| 04260206310075 | K101428 | 000 |
| 04260206310068 | K101428 | 000 |
| 04260206310051 | K101428 | 000 |
| 04260206310044 | K101428 | 000 |
| 04260206310037 | K101428 | 000 |
| 04260206310020 | K101428 | 000 |
| 04260206310013 | K101428 | 000 |
| 04260206311249 | K101428 | 000 |
| 04260206310082 | K101428 | 000 |
| 04260206310099 | K101428 | 000 |
| 04260206310105 | K101428 | 000 |
| 04260206311102 | K101428 | 000 |
| 04260206310334 | K101428 | 000 |
| 04260206310327 | K101428 | 000 |
| 04260206310310 | K101428 | 000 |
| 04260206310303 | K101428 | 000 |
| 04260206310136 | K101428 | 000 |
| 04260206310129 | K101428 | 000 |
| 04260206310112 | K101428 | 000 |
| 04260206311232 | K101428 | 000 |