The following data is part of a premarket notification filed by Domain Surgical, Inc. with the FDA for Domain Surgical System.
| Device ID | K121881 |
| 510k Number | K121881 |
| Device Name: | DOMAIN SURGICAL SYSTEM |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | DOMAIN SURGICAL, INC. 1370 SOUTH 2100 EAST Salt Lake Sity, UT 84108 |
| Contact | Curtis Jensen |
| Correspondent | Curtis Jensen DOMAIN SURGICAL, INC. 1370 SOUTH 2100 EAST Salt Lake Sity, UT 84108 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-26 |
| Decision Date | 2012-10-18 |
| Summary: | summary |