510(k) K133563
- Device
- PATHASSIST LIGHT SEEKER
- Applicant
- Entellus Medical, Inc.
- 510(k) number
- K133563
- Product code
- LRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-12-20
- Date received
- 2013-11-20
- 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
- 3600 Holly Ln. N., Suite 40 Plymouth MN US 55447 55447
FDA Registration Numbers#
- 3023657851
- 9611112
- 9614945
- 3003322138
- 3005440795
- 1825146
- 3003678543
- 3017166758
- 3004215117
- 3006410968
- 3030516433
- 8010591
- 8010282
- 9615857
- 9610617
- 3015967359
- 1421879
- 1056350
- 3010313588
- 1811755
- 3003836856
- 3009307953
- 3003761012
- 8010510
- 1932214
- 3009018440
- 8040278
- 3010041511
- 3007367732
- 1923569
- 3014615697
- 8010269
- 3012964172
- 3008729892
- 3008338766
- 3007689689
- 1057358
- 9613926
- 3025961941
- 3025482817
- 2031917
- 3002806953
- 9680718
- 3013011598
- 8020785
- 8010617
- 1056339
- 1313525
- 3012797688
- 3010455030
- 3013528571
- 2183319
- 1064858
- 3009340886
- 3001614464
- 3010707607
- 3012507533
- 8010523
- 3008087383
- 2183744
- 9615001
- 3004450489
- 3006380247
- 8010704
- 3012267976
- 3015451162
- 3010326886
- 3007583964
- 3020984207
- 3004001706
- 9610773
- 1928237
- 3002858762
- 3002807315
- 3016842760
- 3014345718
- 3010726901
- 3043013991
- 3008388245
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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