Depthalon® 2102-10-059

Depthalon® 2102-10-059 is a Class II device made by Pmt Corp., cleared under FDA 510(k) K151790 on 14 Jul 2016 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00650551040774), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00650551040774 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK151790	Date14 Jul 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00650551040774
FDA 510(k) database 510(k) number K151790

Across registries

2 registries list this device

FDA 510(k) K151790 decided 14 Jul 2016 Active
FDA GUDID UDI-DI 00650551040774 listed 23 Sep 2016 Listed

Timeline

2 dated events

14 Jul 2016 Cleared FDA 510(k) K151790
23 Sep 2016 Listed FDA GUDID 00650551040774

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Depthalon®
Generic name: Depth electrode
Model / Ref / Catalog: 2102-10-059

Primary DI / UDI-DI: 00650551040774
510(k) Number: K151790
FDA product code: GZL
GMDN term: Depth electrode

Device class: Class II
Regulation number: 882.1330
GUDID distribution status: In Commercial Distribution

Other devices from Pmt Corp.

See all devices from Pmt Corp. →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)