The following data is part of a premarket notification filed by Medtronic Advanced Energy, Llc with the FDA for Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, Sbs 5.0 Sheathed Bipolar.
| Device ID | K132974 |
| 510k Number | K132974 |
| Device Name: | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTRONIC ADVANCED ENERGY, LLC 180 INTERNATIONAL DRIVE Portsmouth, NH 03801 |
| Contact | Gabriela Anchondo |
| Correspondent | Gabriela Anchondo MEDTRONIC ADVANCED ENERGY, LLC 180 INTERNATIONAL DRIVE Portsmouth, NH 03801 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-23 |
| Decision Date | 2013-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169868243 | K132974 | 000 |
| 00763000447267 | K132974 | 000 |
| 00763000280895 | K132974 | 000 |
| 00763000280901 | K132974 | 000 |
| 00763000280925 | K132974 | 000 |
| 00763000280949 | K132974 | 000 |
| 00763000047429 | K132974 | 000 |
| 00763000047436 | K132974 | 000 |
| 00763000047443 | K132974 | 000 |
| 00763000047467 | K132974 | 000 |
| 00763000047474 | K132974 | 000 |
| 00643169456204 | K132974 | 000 |
| 00643169456211 | K132974 | 000 |
| 00643169456228 | K132974 | 000 |
| 00643169532205 | K132974 | 000 |
| 00643169868182 | K132974 | 000 |
| 00643169868199 | K132974 | 000 |
| 00643169868229 | K132974 | 000 |
| 00763000447243 | K132974 | 000 |