510(k) K172737
- Device
- MESIRE - Balloon Sinus Dilatation System
- Applicant
- M/s. Meril Life Sciences Private Limited
- 510(k) number
- K172737
- Product code
- LRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-12-12
- Date received
- 2017-09-11
- Regulation
- 874.4420
- Classification name
- Instrument, Ent Manual Surgical
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Umesh Sharma
- Address
- Survey # 135/139, Bilakhia House, Muktanand Marg Chala, Vapi IN 396191 396191
FDA Registration Numbers#
- 8010155
- 3014345718
- 1417592
- 9615857
- 3003678543
- 3013247477
- 3017210488
- 3025961941
- 3012964172
- 3013528571
- 8010547
- 1834331
- 3012797688
- 2029275
- 3010041511
- 9680515
- 9611274
- 3011111237
- 1820334
- 3005172759
- 3006405073
- 1412854
- 3004001706
- 3005900820
- 3007367732
- 3012995405
- 1048735
- 1225984
- 1056350
- 8010374
- 3011237770
- 3008388245
- 3016069968
- 9710524
- 9680721
- 3008280196
- 9610773
- 9613846
- 3004450489
- 1932214
- 8010665
- 1313525
- 8010510
- 1219795
- 3001084743
- 2434839
- 3012226300
- 3007689689
- 3010202439
- 3008902714
- 9610612
- 3004638532
- 1811755
- 3006410968
- 3005528784
- 3010273872
- 3025482817
- 3014342096
- 9614069
- 3006154292
- 3011050570
- 3010269591
- 3030839824
- 2183570
- 3015451162
- 8010168
- 8040278
- 2025182
- 3023464160
- 3011137372
- 1649518
- 3013503739
- 9615001
- 9610905
- 8010298
- 8043752
- 8040233
- 2916714
- 8010269
Source Documents#
Other 510(k) Records For Product Code LRC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230258 | BB 8 Sinus Dilation Kit | Excelent, Inc. | 2023-05-25 |
| K212774 | VenSure LightGuide | Intersect Ent. | 2022-02-04 |
| K201398 | SINUSPRIME Dilation System | Stryker Ent | 2020-10-15 |
| K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | 2020-08-27 |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | 2020-08-26 |
| K181546 | Dillard Nasal Balloon Catheter | Intuit Medical Products, LLC | 2020-01-03 |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent, Inc. | 2019-05-03 |
| K181838 | Sinusway Dilation System | 3nt Medical , Ltd. | 2018-12-20 |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | Acclarent, Inc. | 2017-09-05 |
| K161698 | Relieva UltirraNav Sinus Balloon Catheter | Acclarent, Inc. | 2016-10-24 |
| K160770 | Vent-Os Sinus Dilation family | Sinusys Corporation | 2016-06-29 |
| K153341 | Relieva Scout Multi-Sinus Dilation System | Acclarent, Inc. | 2016-02-12 |
| K152121 | NuVent EM Sinus Dilation System | Medtronic Xomed, Inc. | 2015-12-01 |
| K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015-11-20 |
| K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | 2015-11-20 |
Legacy Summary#
summary
FDA Review#
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