ChitoZolve
510(k) K181696
ChitoZolve is a Class I device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K181696 on 30 Nov 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181696 | Date30 Nov 2018 | StatusActive |
Official records
- FDA 510(k) database K181696
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LYA
- Device class
- Class I
- Regulation
- 21 CFR Part 874.4780
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K181696
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ChitoZolve CNS155 | CNS155 | 00821925044166 | — | On the market |
Similar devices
Other devices filed under FDA product code LYA (Splint, Intranasal Septal).
- DOYLE COMBO NASAL AIRWAY SPLINT by Boston Medical Products, Inc.
- 7247 by Stryker Leibinger
- Bivalve Nasal Splint, Standard 60-302 by Boston Medical Products, Inc.
- Septal splints 2041025 by Spiggle & Theis Medizintechnik GmbH
- Expanding nasal tampon 66100 by Spiggle & Theis Medizintechnik GmbH
- C-FLEX SEPTAL SPLINTS by Trebay Medical Corp.
- 7245 by Stryker Leibinger
- PASSAGE AIRWAY SPLINT by Invotec International, Inc.
- INVOTEC BI-VALVE SPLINT by Invotec International, Inc.
- NASOPORE-FD by Polyganics B.V.,