The following data is part of a premarket notification filed by Microline Surgical, Inc with the FDA for Thermal Ligating Shears.
| Device ID | K122086 |
| 510k Number | K122086 |
| Device Name: | THERMAL LIGATING SHEARS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MICROLINE SURGICAL, INC 800 CUMMING CENTER SUITE 166T Beverly, MA 01915 |
| Contact | William Mccallum |
| Correspondent | William Mccallum MICROLINE SURGICAL, INC 800 CUMMING CENTER SUITE 166T Beverly, MA 01915 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2012-08-23 |
| Summary: | summary |