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Colibrí™ System W090.US

by Copan Wasp Srl

Colibrí™ System W090.US is a Class II device made by Copan Wasp Srl, cleared under FDA 510(k) K220546 on 5 Oct 2022 (1 earlier submission) and listed in FDA GUDID since 27 Jan 2022 (UDI-DI 58052870816202), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220546 Date5 Oct 2022DecidedStatusActive
United StatesGUDID listing Number58052870816202 UDI-DI Date27 Jan 2022ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220546 decided 5 Oct 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 58052870816202 listed 27 Jan 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K193138
  2. Listed FDA GUDID 58052870816202
  3. Cleared FDA 510(k) K220546

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Colibrí™ System
Generic name
Microbial specimen inoculation/streaking/colony-picking instrument IVD
Model / Ref / Catalog
W090.US
Primary DI / UDI-DI
58052870816202
510(k) Number
FDA product code
QQV, QBN, LON
GMDN term
Microbial specimen inoculation/streaking/colony-picking instrument IVD
Device class
Class II
Regulation number
866.3378, 866.1645
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code QBN.

Other devices from Copan Wasp Srl

See all devices from Copan Wasp Srl →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)