Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K190372
Aveta System · Meditrina, Inc. · decided 2019-05-16 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Aveta Opal Disposable Hysteroscope, 4.6mm | 220-2002 | MEDITRINA, INC. | HIG HIH | 00850006759569 |
| Aveta Smol Disposable Resecting Device, 2.9 mm | 204-239 | MEDITRINA, INC. | HIG HIH | 00850006759460 |
| Aveta Disposable Resecting Device 3.9 mm | 216-041 | MEDITRINA, INC. | HIG HIH | 00850006759095 |
| Aveta Waste Management Accessory | 205-2003 | MEDITRINA, INC. | HIG HIH | 00850006759446 |
| Aveta Waste Bag. 6L | 205-105 | MEDITRINA, INC. | HIG HIH | 00850006759118 |
| Aveta Tissue Catch | 205-259 | MEDITRINA, INC. | HIG HIH | 00850006759163 |
| Aveta Max Disposable Resecting Device, 3.9 mm | 210-084 | MEDITRINA, INC. | HIG HIH | 00850006759323 |
| Aveta Roll Stand with Drape Pump | 212-205 | MEDITRINA, INC. | HIG HIH | 00850006759033 |
| Aveta Flex Disposable Resecting Device, 2.9 mm | 210-080 | MEDITRINA, INC. | HIG HIH | 00850006759316 |
| Aveta Fluid Management Accessory | 205-212 | MEDITRINA, INC. | HIG HIH | 00850006759231 |
| Aveta Pearl Disposable Hysteroscope | 214-059 | MEDITRINA, INC. | HIG HIH | 00850006759064 |
| Aveta Fluid Management Accessory | 205-072 | MEDITRINA, INC. | HIG HIH | 00850006759002 |
| Aveta Wave+ Disposable Resecting Device, 3.9 mm | 210-2005 | MEDITRINA, INC. | HIG HIH | 00850006759590 |
| Aveta Controller | 212-080 | MEDITRINA, INC. | HIG HIH | 00850006759019 |
| Aveta Smol Disposable Resecting Device, 2.9 mm | 204-210 | MEDITRINA, INC. | HIG HIH | 00850006759484 |
| Aveta Waste Bag with Tissue Catch | 205-2037 | MEDITRINA, INC. | HIG HIH | 00850006759736 |
| Aveta Reusable Resecting Handset | 211-001 | MEDITRINA, INC. | HIG HIH | 00850006759040 |
| Aveta Pearl Disposable Hysteroscope | 214-228 | MEDITRINA, INC. | HIG HIH | 00850006759262 |
| Aveta Smol Disposable Resecting Device, 2.9 mm | 216-2008 | MEDITRINA, INC. | HIG HIH | 00850006759613 |
| Aveta Disposable Resecting Handset | 213-029 | MEDITRINA, INC. | HIG HIH | 00850006759071 |
| Aveta Waste Bag | 205-2000 | MEDITRINA, INC. | HIG HIH | 00850006759361 |
| Aveta Waste Management Accessory | 205-2036 | MEDITRINA, INC. | HIG HIH | 00850006759699 |
| Aveta Tissue Catch with Tubing | 205-2052 | MEDITRINA, INC. | HIG HIH | 00850006759835 |
| Aveta Opal Reusable Cable | 220-2011 | MEDITRINA, INC. | HIG HIH | 00850006759583 |
| Aveta Disposable Resecting Handset | 213-060 | MEDITRINA, INC. | HIG HIH | 00850006759279 |