510(k) K130354
- Device
- MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
- Applicant
- ENTRIGUE SURGICAL, INC.
- 510(k) number
- K130354
- Product code
- LYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-05-29
- Date received
- 2013-02-12
- Regulation
- 874.4780
- Classification name
- Splint, Intranasal Septal
- 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
- GABRIELE G NIEDERAUER
- Address
- 12672 Silicon Dr. Suite 150 San Antonio TX US 78249 78249
FDA Registration Numbers#
- 3022140316
- 3015967359
- 1526711
- 1625425
- 3003775072
- 1061124
- 3030653921
- 3010951382
- 9611024
- 3013517086
- 3006306415
- 3003477135
- 3008729892
- 3016050930
- 3010880816
- 3004146122
- 9612501
- 3004111573
- 1226544
- 3002806953
- 3015174190
- 3006524618
- 2183319
- 2135339
- 3010610457
- 2183744
- 3040335671
- 3032857006
- 3010951384
- 1450662
- 2031093
- 1928237
- 3002858762
- 3002807315
- 3014345718
- 3007788086
- 3010952189
- 3011050570
- 1645368
- 3004050854
- 1424263
- 1018470
- 3016678045
- 3021082429
- 1219795
- 3010273872
- 3003915875
- 2110420
- 3003418325
- 8010177
- 3005112833
- 3015337116
- 3030733800
- 3007327621
- 1058584
- 9612051
- 3011400126
- 1213643
- 3023464160
- 3007225047
- 3017636737
- 2028632
- 3010487482
- 1649518
- 3006345872
- 3003364789
- 1037007
- 3034731665
- 3002789796
- 1223089
- 3009403363
- 2029275
- 1319660
- 3008812251
- 2246552
- 2028807
- 3010872396
- 3012448339
- 1643264
- 3012358417
Source Documents#
Other 510(k) Records For Product Code LYA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243655 | TurbAlign | Spirair, Inc. | 2025-07-11 |
| K230142 | Epi-Stop Nasal Gel/epistaxis pack | Biomed Ent, Inc. | 2023-03-22 |
| K213153 | SPIWay Endonasal Access Guide | Spiway, LLC | 2021-10-27 |
| K202623 | Novapak Nasal Sinus Packing and Stent | Medtronic Xomed | 2020-12-08 |
| K181696 | ChitoZolve | Gyrus Acmi, Inc. | 2018-11-30 |
| K180141 | SPIWay Endonasal Access Guide | Spiway, LLC | 2018-02-16 |
| K170913 | Composite Removable Sinus Stent System | Sts Medical | 2017-12-15 |
| K172179 | Chitogel Endoscopic Sinus Surgery Kit | Chitogel, Ltd. | 2017-10-17 |
| K153686 | SPIWay Endonasal Access Guide | Spiway, LLC | 2016-01-28 |
| K141816 | HEMOPORE | Polyganics B.V., | 2014-10-23 |
| K141704 | NOVASHIELD INJECTABLE NASAL PACKING AND STENT | Medtronic, Inc. | 2014-10-06 |
| K141423 | NASOPORE-FD | Polyganics B.V., | 2014-08-07 |
| K140992 | ARTHROCARE NASASTENT CMC NASAL DRESSING | ArthroCare Corporation | 2014-06-16 |
| K132721 | SPIWAY ENDONASAL ACCESS GUIDE | Spiway, LLC | 2014-01-29 |
| K122494 | POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT | Hemostasis, LLC | 2013-03-27 |
Legacy Summary#
summary
FDA Review#
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