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TRACOE technic REF 702

by Tracoe medical GmbH

TRACOE technic REF 702 is an artificial airway cuff inflation tubing (FDA Class II; FDA product code BSK, Cuff, tracheal tube, inflatable) made by Tracoe medical GmbH, cleared under FDA 510(k) K152778 on 21 Dec 2016 and listed in FDA GUDID since 19 Sep 2019 (UDI-DI 04035324046317), 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) K152778

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 Number04035324046317 UDI-DI Date19 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152778 Date21 Dec 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152778 decided 21 Dec 2016 Active
  • FDA GUDID UDI-DI 04035324046317 listed 19 Sep 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152778
  2. Listed FDA GUDID 04035324046317

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TRACOE technic
Generic name
Artificial airway cuff inflation tubing
Model / Ref / Catalog
REF 702
Primary DI / UDI-DI
04035324046317
510(k) Number
FDA product code
BSK
GMDN term
Artificial airway cuff inflation tubing
Device class
Class II
Regulation number
868.5750
GUDID distribution status
In Commercial Distribution
Size
Length — 100 Centimeter

Related devices

Category: Artificial airway cuff inflation tubing

Similar devices

Other devices filed under FDA product code BSK (Cuff, tracheal tube, inflatable).

Other devices from Tracoe medical GmbH

See all devices from Tracoe medical GmbH →

Properties

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