The following data is part of a premarket notification filed by Acessa Health, Inc. with the FDA for Acessa Provu System.
| Device ID | K181124 |
| 510k Number | K181124 |
| Device Name: | Acessa ProVu System |
| Classification | Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Applicant | Acessa Health, Inc. 7004 Bee Cave Road, Bldg 3, Suite 200 Austin, TX 78746 |
| Contact | Brian J. Bergeron |
| Correspondent | Kim Rodriguez Acessa Health, Inc. 7004 Bee Cave Road, Bldg 3, Suite 200 Austin, TX 78746 |
| Product Code | HFG |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | OEW |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-30 |
| Decision Date | 2018-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854763006256 | K181124 | 000 |