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ChitoZolve CNS155

by Gyrus Acmi, Inc.

Ref CNS155

ChitoZolve CNS155 is a device classified as Class III in the EU and Class I in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-00821925044159), cleared under FDA 510(k) K181696 on 30 Nov 2018 and listed in FDA GUDID since 3 Dec 2020 (UDI-DI 00821925044159), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181696

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925044159 Basic UDI-DI 00821925044159UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925044159 UDI-DI Date3 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181696 Date30 Nov 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00821925044159 registered 21 Oct 2026 Active
  • FDA 510(k) K181696 decided 30 Nov 2018 Active
  • FDA GUDID UDI-DI 00821925044159 listed 3 Dec 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181696
  2. Listed FDA GUDID 00821925044159
  3. Registered EUDAMED B-00821925044159

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ChitoZolve
Generic name
Intranasal splint, non-bioabsorbable, animal-derived
Device name
CNS155
Model / reference
CNS155
Primary DI / UDI-DI
00821925044159 EUDAMED
00821925044166 GUDID
Basic UDI-DI
B-00821925044159
510(k) Number
FDA product code
LYA
EMDN code
P020202 Nasal sinus stents
GMDN term
Intranasal splint, non-bioabsorbable, animal-derived
Device class
Class III EUDAMED
Class I GUDID
Regulation number
874.4780
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925044159
GUDID
00821925044166
Device classEUDAMED
Class III
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821925044159; FDA GUDID lists 00821925044166), so their flags are not compared. Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Intranasal splint, non-bioabsorbable, animal-derived

Similar devices in this category

Other devices filed under RHINOLOGY PROSTHESES.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)