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Duplotip SA374003000000

by Micromedics, Inc.

Duplotip SA374003000000 is an ENT cabinet (FDA Class II; FDA product code FMF, Syringe, Piston) made by Micromedics, Inc., cleared under FDA 510(k) K033589 on 4 Oct 2004 and listed in FDA GUDID since 25 Sep 2016 (UDI-DI 00815634020122), active as of 22 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 22 Oct 2026

Documents

510(k) K033589

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00815634020122 UDI-DI Date25 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK033589 Date4 Oct 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K033589 decided 4 Oct 2004 Active
  • FDA GUDID UDI-DI 00815634020122 listed 25 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K033589
  2. Listed FDA GUDID 00815634020122

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Duplotip
Generic name
ENT cabinet
Model / reference
SA374003000000
Primary DI / UDI-DI
00815634020122
510(k) Number
FDA product code
FMF
GMDN term
ENT cabinet
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution

Related devices

Category: ENT cabinet

Cleared under the same submission (K033589)

and 2 more cleared under K033589

Similar devices

Other devices filed under FDA product code FMF (Syringe, Piston).

Other devices from Micromedics, Inc.

See all devices from Micromedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)