The following data is part of a premarket notification filed by Domain Surgical, Inc. with the FDA for Fmwand Ferromagnetic Surgical System.
| Device ID | K130606 |
| 510k Number | K130606 |
| Device Name: | FMWAND FERROMAGNETIC SURGICAL SYSTEM |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | DOMAIN SURGICAL, INC. 1370 S 2100 E Salt Lake City, UT 84108 |
| Contact | Curtis Jensen |
| Correspondent | Curtis Jensen DOMAIN SURGICAL, INC. 1370 S 2100 E Salt Lake City, 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 | 2013-03-07 |
| Decision Date | 2014-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20859729006091 | K130606 | 000 |
| 20859729006084 | K130606 | 000 |
| 20859729006077 | K130606 | 000 |
| 20859729006060 | K130606 | 000 |
| 20859729006053 | K130606 | 000 |
| 00859729006028 | K130606 | 000 |
| 00859729006011 | K130606 | 000 |