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Gyrus Acmi 70140271

by Gyrus Acmi, Inc.

Gyrus Acmi 70140271 is a tympanostomy tube (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Gyrus Acmi, Inc., cleared under FDA 510(k) K000801 on 19 Jun 2000 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00821925039643), 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) K000801

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 Number00821925039643 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK000801 Date19 Jun 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K000801 decided 19 Jun 2000 Active
  • FDA GUDID UDI-DI 00821925039643 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K000801
  2. Listed FDA GUDID 00821925039643

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Gyrus Acmi
Generic name
Tympanostomy tube
Model / reference
70140271
Primary DI / UDI-DI
00821925039643
510(k) Number
FDA product code
ETD
GMDN term
Tympanostomy tube
Device class
Class II
Regulation number
874.3880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tympanostomy tube

Cleared under the same submission (K000801)

and 8 more cleared under K000801

Similar devices in this category

Other devices filed under Tympanostomy tube.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)