The following data is part of a premarket notification filed by Spiration, Inc. with the FDA for Active Needle Endoscopic Treatment (anet) Electrosurgical Applicator.
| Device ID | K170990 |
| 510k Number | K170990 |
| Device Name: | Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Spiration, Inc. 6675 185th Avenue NE Redmond, WA 98052 |
| Contact | Cheryl Frederick |
| Correspondent | Cheryl Frederick Spiration, Inc. 6675 185th Avenue NE Redmond, WA 98052 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-03 |
| Decision Date | 2017-05-11 |
| Summary: | summary |