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Sinuscope R00

by Ecleris 20 variants

Sinuscope R00 (SN104) is a Class II device made by Ecleris, cleared under FDA 510(k) K030572 on 1 Apr 2003 and listed in FDA GUDID since 16 Nov 2022 (UDI-DI B366SN104), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K030572

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB366SN104 UDI-DI Date16 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK030572 Date1 Apr 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K030572 decided 1 Apr 2003 Active
  • FDA GUDID UDI-DI B366SN104 listed 16 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K030572
  2. Listed FDA GUDID B366SN104

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sinuscope
Generic name
Rigid optical sinoscope
Model / Ref / Catalog
R00, SN104
Primary DI / UDI-DI
B366SN104
510(k) Number
FDA product code
EOB
GMDN term
Rigid optical sinoscope
Device class
Class II
Regulation number
874.4760
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rigid optical sinoscope

Cleared under the same submission (K030572)

and 8 more cleared under K030572

Similar devices

Other devices filed under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)).

Other devices from Ecleris

See all devices from Ecleris →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)