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Owl D467-005-Tch

by Diros Technology, Inc.

Owl D467-005-Tch is a Class II device made by Diros Technology, Inc., cleared under FDA 510(k) K110593 on 5 May 2011 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 00825114006256), 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) K110593

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 Number00825114006256 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK110593 Date5 May 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110593 decided 5 May 2011 Active
  • FDA GUDID UDI-DI 00825114006256 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110593
  2. Listed FDA GUDID 00825114006256

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Owl
Generic name
Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
Model / Ref / Catalog
D467-005-TCH
Primary DI / UDI-DI
00825114006256
510(k) Number
FDA product code
GXI
GMDN term
Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
Device class
Class II
Regulation number
882.4725
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use

Cleared under the same submission (K110593)

and 7 more cleared under K110593

Similar devices

Other devices filed under FDA product code GXI (Probe, Radiofrequency Lesion).

Other devices from Diros Technology, Inc.

See all devices from Diros Technology, Inc. →

Properties

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