Owl 466-021/50/2

by Diros Technology, Inc.

Owl 466-021/50/2 is a Class II device made by Diros Technology, Inc., cleared under FDA 510(k) K102566 on 3 Jun 2011 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 00825114003651), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00825114003651 UDI-DI	Date1 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK102566	Date3 Jun 2011Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00825114003651
FDA 510(k) database 510(k) number K102566

Across registries

2 registries list this device

FDA 510(k) K102566 decided 3 Jun 2011 Active
FDA GUDID UDI-DI 00825114003651 listed 1 Sep 2016 Listed

Timeline

2 dated events

3 Jun 2011 Cleared FDA 510(k) K102566
1 Sep 2016 Listed FDA GUDID 00825114003651

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Owl
Generic name: Percutaneous radio-frequency ablation probe cannula, single-use
Model / Ref / Catalog: 466-021/50/2

Primary DI / UDI-DI: 00825114003651
510(k) Number: K102566
FDA product code: GXI
GMDN term: Percutaneous radio-frequency ablation probe cannula, single-use

Device class: Class II
Regulation number: 882.4725
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

Other devices from Diros Technology, Inc.

OWL GD-Pad Patient Return Electrode (Split Type, Non-Corded)

Class IIb
OWL GD-Pad Patient Return Electrode (Split Type, Corded)

Class IIb
OWL GD-Pad Patient Return Electrode (Corded)

Class IIb
OWL GD-Pad Patient Return Electrode (Non-Corded)

Class IIb

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)