The following data is part of a premarket notification filed by Genii, Inc. with the FDA for Genii Arc Smart Argon Probe.
| Device ID | K130983 |
| 510k Number | K130983 |
| Device Name: | GENII ARC SMART ARGON PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GENII, INC. 3640 PILLSBURY AVE Minneapolis, MN 55409 |
| Contact | Tracy Eberly |
| Correspondent | Tracy Eberly GENII, INC. 3640 PILLSBURY AVE Minneapolis, MN 55409 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-09 |
| Decision Date | 2013-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995209107 | K130983 | 000 |
| 10724995209091 | K130983 | 000 |
| 10724995209084 | K130983 | 000 |