The following data is part of a premarket notification filed by Halt Medical Inc. with the FDA for Acessa Guidance System.
| Device ID | K132744 |
| 510k Number | K132744 |
| Device Name: | ACESSA GUIDANCE SYSTEM |
| Classification | Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Applicant | HALT MEDICAL INC. 131 Sand Creek Road, Suite B Brentwood, CA 94513 |
| Contact | Clarisa Tate |
| Correspondent | Clarisa Tate HALT MEDICAL INC. 131 Sand Creek Road, Suite B Brentwood, CA 94513 |
| Product Code | HFG |
| 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 | 2013-09-03 |
| Decision Date | 2014-05-27 |
| Summary: | summary |