510(k) K120735
- Device
- PATHASSIT LIGHT SEEKER
- Applicant
- Entellus Medical, Inc.
- 510(k) number
- K120735
- Product code
- LRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-02
- Date received
- 2012-03-09
- Regulation
- 874.4420
- Classification name
- Instrument, Ent Manual Surgical
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARRETT P AHLBORG
- Address
- 6705 Wedgwood Ct. N. Maple Grove MN US 55311 55311
FDA Registration Numbers#
- 9681147
- 1061771
- 2029275
- 3015451162
- 3017166758
- 9614069
- 9610612
- 8010617
- 8043441
- 9680837
- 3014334038
- 8010704
- 3011310592
- 3012167431
- 1057421
- 3005423519
- 1219653
- 9611262
- 2025182
- 3006345872
- 3005809810
- 8043752
- 3007421149
- 3009092818
- 8010177
- 3036795921
- 3009307953
- 3011237770
- 8044098
- 3011050570
- 8010374
- 3005067367
- 3010202439
- 2135225
- 3012964172
- 1047843
- 3018094310
- 3008843439
- 1421101
- 1048735
- 9617426
- 9710014
- 3031842642
- 3003678543
- 3004608878
- 9610621
- 1928237
- 1123010
- 3004001706
- 1018470
- 3005216725
- 3004950803
- 1064858
- 3006154292
- 9611102
- 3007689689
- 3008729892
- 1056339
- 9710524
- 3007583964
- 3016069968
- 3027822140
- 3010149039
- 1923569
- 3010455030
- 3003761012
- 3013497507
- 9611274
- 9611112
- 3010273872
- 3010726901
- 3007225047
- 1219795
- 3003790304
- 9610773
- 3013528571
- 3009018440
- 1037007
- 1313525
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 |
| K172737 | MESIRE - Balloon Sinus Dilatation System | M/S. Meril Life Sciences Private Limited | 2017-12-12 |
| 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 |
Legacy Summary#
summary
FDA Review#
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