Minerva Genesys HTA Endometrial Ablation System
Minerva Surgical, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011011193 | 3011011193 | MINERVA SURGICAL, INC. | 1 | Y | 2026-01-01 | 4255 Burton Drive Santa Clara CA US 95054 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850033976267 | HERizon Disposable Electronic Hysteroscope - Disposable Electronic Hysteroscope For Use with HERizon Medical Endoscope Image Processor | 855-646-7874 | customerservice@axoramedical.com |
| 00850033976274 | HERizon Disposable Endoscopic Forceps - Biopsy - Disposable Endoscopic Forceps - Biopsy | 855-646-7874 | customerservice@axoramedical.com |
| 00850033976281 | HERizon Disposable Endoscopic Forceps - Foreign Body Grasper - Disposable Endoscopic Forceps - Foreign Body Grasper | 855-646-7874 | customerservice@axoramedical.com |
| 00850033976298 | HERizon Disposable Endoscopic Forceps – Alligator - Disposable Endoscopic Forceps – Alligator | 855-646-7874 | Customerservice@axoramedical.com |
| 00850033976304 | HERizon Disposable Endoscopic Forceps - Inverted Tooth - Disposable Endoscopic Forceps - Inverted Tooth | 855-646-7874 | customerservice@axoramedical.com |
| 00850033976311 | HERizon Disposable Endoscopic Scissors - Disposable Endoscopic Scissors | 855-646-7874 | Customerservice@axoramedical.com |
| 00850033976335 | Symphion Operative Hysteroscopy System Prime Controller - Symphion Operative Hysteroscopy System Controller with Integrated Fluid Management Contents: (1) Symphion Controller (1) Power Cord (1) Footswitch (1) Saline Pole | 855-646-7874 | customerservice@axoramedical.com |
| 00850033976359 | HERizon Disposable Endoscopic Scissors XL - Disposable Endoscopic Scissors XL | 855-646-7874 | Customerservice@axoramedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 185396 | 1210688005 | P140013 | MINERVA ENDOMETRIAL ABLATION SYSTEM | MNB | 2015-07-27 |
| 185396 | 1597125532 | P000040 | HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM | MNB | 2001-04-20 |
| 185396 | 1550187767 | K233710 | Symphion Operative Hysteroscopy System | PGT | 2024-01-17 |
| 185396 | 1175741298 | K191538 | Resectr Tissue Resection Device | HIH | 2020-01-16 |
| 185396 | 1359922092 | K160751 | Symphion Endoscope and Symphion Cervical Sheath | HIH | 2016-06-14 |
| 185396 | 1461710762 | K141848 | IOGYN SYSTEM | PGT | 2014-08-29 |
| 185396 | 1411550106 | ||||
| 185396 | 1974269071 | ||||
| 185396 | 1990699286 |
Minerva Surgical, Inc.
Minerva Surgical, Inc.
Minerva Surgical, Inc.
2024-10-07
2024-10-07
2024-10-07
2024-10-07
2024-10-07
2024-10-07
2025-10-31
2026-02-13
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2026-02-13
2024-10-07
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2017-06-27
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2026-02-13