Nim 8225825X

by Medtronic Xomed Inc

Nim 8225825X is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K213246 on 21 Mar 2022 and listed in FDA GUDID since 17 Jun 2022 (UDI-DI 20763000112459), active as of 8 Nov 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 8 Nov 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number20763000112459 UDI-DI	Date17 Jun 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK213246	Date21 Mar 2022Decided	StatusActive

Official records

AccessGUDID record UDI-DI 20763000112459
FDA 510(k) database 510(k) number K213246

Across registries

2 registries list this device

FDA 510(k) K213246 decided 21 Mar 2022 Active
FDA GUDID UDI-DI 20763000112459 listed 17 Jun 2022 Listed

Timeline

2 dated events

21 Mar 2022 Cleared FDA 510(k) K213246
17 Jun 2022 Listed FDA GUDID 20763000112459

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Nim
Generic name: Nerve-locating system probe, single-use
Model / reference: 8225825X

Primary DI / UDI-DI: 20763000112459
510(k) Number: K213246
FDA product code: ETN
GMDN term: Nerve-locating system probe, single-use

Device class: Class II
Regulation number: 874.1820
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Nerve-locating system probe, single-use.

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number

Other properties (11, all answered No)