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Colibrí

by Copan Wasp Srl 2 variants

510(k) K223245

Colibrí is a Class II device made by Copan Wasp Srl, cleared under FDA 510(k) K223245 on 20 Mar 2023, active as of 8 Nov 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223245 Date20 Mar 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QQV
Device class
Class II
Regulation
21 CFR Part 866.3378
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

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