The following data is part of a premarket notification filed by Actuated Medical, Inc. with the FDA for Tubeclear System.
| Device ID | K172556 |
| 510k Number | K172556 |
| Device Name: | TubeClear System |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Actuated Medical, Inc. 310 Rolling Ridge Dr. Bellefonte, PA 16823 |
| Contact | Michael T. Britton |
| Correspondent | Michael T. Britton Actuated Medical, Inc. 310 Rolling Ridge Dr. Bellefonte, PA 16823 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-24 |
| Decision Date | 2018-06-29 |
| Summary: | summary |