510(k) K183015
- Device
- PuraSinus
- Applicant
- 3-D Matrix, Inc.
- 510(k) number
- K183015
- Product code
- NHB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-04-12
- Date received
- 2018-10-31
- Regulation
- 874.3620
- Classification name
- Polymer, Ear, Nose And Throat, Synthetic, Absorbable
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lisa Spirio
- Address
- 250 First Ave., Suite 205 Needham MA US 02494 02494
FDA Registration Numbers#
- 3005465238
- 1058584
- 3022140316
- 3007162658
- 3017102971
- 1213643
- 3007225047
- 1450662
- 3015967359
- 1825034
- 3006345872
- 1061124
- 1811755
- 3030653921
- 1423662
- 3011088743
- 3008791915
- 1223089
- 3002294946
- 2029275
- 1424263
- 1220477
- 2183967
- 3043562110
- 3005941719
- 3009736544
- 2032098
- 2183319
- 3012448339
- 3015528146
- 2210968
- 3012263097
- 3004681519
- 2953359
- 3040335671
- 3005689226
- 3017210488
Source Documents#
Other 510(k) Records For Product Code NHB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251790 | SeptAlign | Spirair, Inc. | 2026-01-16 |
| K233569 | SeptAlign | Spirair, Inc. | 2024-03-22 |
| K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | 2023-08-17 |
| K210411 | PosiSep EAR Fragmentable Ear Dressing | Hemostasis, LLC | 2022-05-05 |
| K192661 | LATERA Absorbable Nasal Implant System | Entellus Medical, Inc. (Aka Stryker Ent) | 2019-11-10 |
| K161191 | Latera Absorbable Nasal Implant | Spirox, Inc. | 2016-06-23 |
| K152958 | INEX Absorbable Nasal Implant | Spirox, Inc. | 2015-12-04 |
| K132920 | SPIROX INEX DEVICE | Spirox, Inc. | 2014-06-10 |
| K122434 | MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL | Medtronic Xomed | 2012-10-31 |
| K092590 | PDS PLATES | ETHICON, Inc. | 2010-02-17 |
| K070715 | NASOPORE EAR | Polyganics B.V., | 2007-05-07 |
| K070886 | MEROGEL INJECTABLE BIORESORBABLE STENT | Medtronic, Inc. | 2007-04-26 |
| K012769 | MACROPORE ENT RECONSTRUCTION FILM | Macropore Biosurgery, Inc. | 2001-10-25 |
| K012409 | LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS | Walter Lorenz Surgical, Inc. | 2001-10-18 |