The following data is part of a premarket notification filed by Schlumbohm Gmbh & Co. Kg with the FDA for Endopilot2.
| Device ID | K202906 |
| 510k Number | K202906 |
| Device Name: | EndoPilot2 |
| Classification | Scaler, Ultrasonic |
| Applicant | Schlumbohm GmbH & Co. KG Klein Floyen 8-10 Brokstedt, DE D-24616 |
| Contact | Gerald Schlumbohm |
| Correspondent | Oliver Eikenberg Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | ELC |
| Subsequent Product Code | EKR |
| Subsequent Product Code | EKX |
| Subsequent Product Code | LQY |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260482991029 | K202906 | 000 |
| 04260482990190 | K202906 | 000 |
| 04260482991135 | K202906 | 000 |
| 04260482990084 | K202906 | 000 |
| 04260482990602 | K202906 | 000 |
| 04260482990763 | K202906 | 000 |
| 04260482990787 | K202906 | 000 |
| 04260482990817 | K202906 | 000 |
| 04260482990923 | K202906 | 000 |
| 04260482990282 | K202906 | 000 |
| 04260482990305 | K202906 | 000 |
| 04260482990589 | K202906 | 000 |
| 04260482990596 | K202906 | 000 |
| 04260482990893 | K202906 | 000 |
| 04260482990916 | K202906 | 000 |
| 04260482990091 | K202906 | 000 |
| 04260482990824 | K202906 | 000 |