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Astra Tee A9009-01

by Civco Medical Instruments Co., Inc.

Astra Tee A9009-01 (610-1338) is a Class II device made by Civco Medical Instruments Co., Inc., cleared under FDA 510(k) K150504 on 16 Nov 2015 and listed in FDA GUDID since 23 Aug 2017 (UDI-DI 00841436111287), 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) K150504

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 Number00841436111287 UDI-DI Date23 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150504 Date16 Nov 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150504 decided 16 Nov 2015 Active
  • FDA GUDID UDI-DI 00841436111287 listed 23 Aug 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150504
  2. Listed FDA GUDID 00841436111287

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Astra Tee
Generic name
Ultrasound imaging transducer washer-disinfector (chemical)
Model / Ref / Catalog
A9009-01, 610-1338
Primary DI / UDI-DI
00841436111287
510(k) Number
FDA product code
ITX
GMDN term
Ultrasound imaging transducer washer-disinfector (chemical)
Device class
Class II
Regulation number
892.1570
GUDID distribution status
In Commercial Distribution
Size
Width — 12 Inch
Height — 48 Inch

Related devices

Category: Ultrasound imaging transducer washer-disinfector (chemical)

Cleared under the same submission (K150504)

Similar devices

Other devices filed under FDA product code ITX (Transducer, ultrasonic, diagnostic).

Other devices from Civco Medical Instruments Co., Inc.

See all devices from Civco Medical Instruments Co., Inc. →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)