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Aveta System

by Meditrina, Inc. 2 variants

510(k) K190372

Aveta System is a Class II device made by Meditrina, Inc., cleared under FDA 510(k) K190372 on 16 May 2019, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190372 Date16 May 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HIH
Device class
Class II
Regulation
21 CFR Part 884.1690
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K190372

34 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K190372
UDI-DISize and differences
Aveta Auto Disposable Resecting Device 215-010
Meditrina, Inc.
215-010 / 215-01000850006759545
Single use: yes
On the market
Aveta Cervical Seal 214-2017
Meditrina, Inc.
214-2017 / 214-201700850006759507
Single use: yes
On the market
Aveta Controller 212-080
Meditrina, Inc.
212-080 / 212-08000850006759019
Single use: no
On the market
Aveta Coral Disposable Hysteroscope 214-057
Meditrina, Inc.
214-057 / 214-05700850006759057
Single use: yes
On the market
Aveta Coral Disposable Hysteroscope 214-251
Meditrina, Inc.
214-251 / 214-25100850006759293
Single use: yes
On the market
Aveta Disposable Resecting Device 2.9 mm 204-167
Meditrina, Inc.
204-167 / 204-16700850006759088
Single use: yes
On the market
Aveta Disposable Resecting Device 3.9 mm 216-041
Meditrina, Inc.
216-041 / 216-04100850006759095
Single use: yes
On the market
Aveta Disposable Resecting Handset 213-029
Meditrina, Inc.
213-029 / 213-02900850006759071
Single use: yes
On the market
Aveta Disposable Resecting Handset 213-060
Meditrina, Inc.
213-060 / 213-06000850006759279
Single use: yes
On the market
Aveta Flex Disposable Resecting Device, 2.9 mm 210-080
Meditrina, Inc.
210-080 / 210-08000850006759316
Single use: yes
On the market
Aveta Fluid Management Accessory 205-072
Meditrina, Inc.
205-072 / 205-07200850006759002
Single use: yes
On the market
Aveta Fluid Management Accessory 205-212
Meditrina, Inc.
205-212 / 205-21200850006759231
Single use: yes
On the market
Aveta Max Disposable Resecting Device, 3.9 mm 210-084
Meditrina, Inc.
210-084 / 210-08400850006759323
Single use: yes
On the market
Aveta Opal Disposable Hysteroscope, 4.6mm 220-2002
Meditrina, Inc.
220-2002 / 220-200200850006759569
Single use: yes
On the market
Aveta Opal Reusable Cable 220-2011
Meditrina, Inc.
220-2011 / 220-201100850006759583
Single use: no
On the market
Aveta Pearl Disposable Hysteroscope 214-059
Meditrina, Inc.
214-059 / 214-05900850006759064
Single use: yes
On the market
Aveta Pearl Disposable Hysteroscope 214-228
Meditrina, Inc.
214-228 / 214-22800850006759262
Single use: yes
On the market
Aveta Reusable Resecting Handset 211-001
Meditrina, Inc.
211-001 / 211-00100850006759040
Single use: no
On the market
Aveta Roll Stand with Drape Pump 212-205
Meditrina, Inc.
212-205 / 212-20500850006759033
Single use: no
On the market
Aveta Smol Disposable Resecting Device, 2.9 mm 204-210
Meditrina, Inc.
204-210 / 204-21000850006759484
Single use: yes
On the market
Aveta Smol Disposable Resecting Device, 2.9 mm 204-239
Meditrina, Inc.
204-239 / 204-23900850006759460
Single use: yes
On the market
Aveta Smol Disposable Resecting Device, 2.9 mm 210-100
Meditrina, Inc.
210-100 / 210-10000850006759309
Single use: yes
On the market
Aveta Smol Disposable Resecting Device, 2.9 mm 216-2008
Meditrina, Inc.
216-2008 / 216-200800850006759613
Single use: yes
On the market
Aveta Tissue Catch 205-259
Meditrina, Inc.
205-259 / 205-25900850006759163
Single use: yes
On the market
Aveta Tissue Catch with Suction Tubing 205-116
Meditrina, Inc.
205-116 / 205-11600850006759101
Single use: yes
On the market
Aveta Tissue Catch with Tubing 205-2052
Meditrina, Inc.
205-2052 / 205-205200850006759835
Single use: yes
On the market
Aveta Waste Bag 205-2000
Meditrina, Inc.
205-2000 / 205-200000850006759361
Single use: yes
On the market
Aveta Waste Bag with Tissue Catch 205-2037
Meditrina, Inc.
205-2037 / 205-203700850006759736
Single use: yes
On the market
Aveta Waste Bag. 6L 205-105
Meditrina, Inc.
205-105 / 205-10500850006759118
Single use: yes
On the market
Aveta Waste Management Accessory 205-2001
Meditrina, Inc.
205-2001 / 205-200100850006759385
Single use: yes
On the market
Aveta Waste Management Accessory 205-2003
Meditrina, Inc.
205-2003 / 205-200300850006759446
Single use: yes
On the market
Aveta Waste Management Accessory 205-2036
Meditrina, Inc.
205-2036 / 205-203600850006759699
Single use: yes
On the market
Aveta Waste Management Accessory 205-224
Meditrina, Inc.
205-224 / 205-22400850006759149
Single use: yes
On the market
Aveta Wave+ Disposable Resecting Device, 3.9 mm 210-2005
Meditrina, Inc.
210-2005 / 210-200500850006759590
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code HIH (Hysteroscope (And Accessories)).

Other devices from Meditrina, Inc.

See all devices from Meditrina, Inc. →