Ez Spray

by Nakanishi Inc.

Ez Spray is a Class I device made by Nakanishi Inc., cleared under FDA 510(k) K163483 on 15 Aug 2017 and listed in FDA GUDID since 1 Nov 2024 (UDI-DI 04589551392063), active as of 21 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 21 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04589551392063 UDI-DI	Date1 Nov 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK163483	Date15 Aug 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04589551392063
FDA 510(k) database 510(k) number K163483

Across registries

2 registries list this device

FDA 510(k) K163483 decided 15 Aug 2017 Active
FDA GUDID UDI-DI 04589551392063 listed 1 Nov 2024 Listed

Timeline

2 dated events

15 Aug 2017 Cleared FDA 510(k) K163483
1 Nov 2024 Listed FDA GUDID 04589551392063

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Surgical instrument maintenance lubricant
Model / reference: EZ SPRAY

Primary DI / UDI-DI: 04589551392063
510(k) Number: K163483
FDA product code: EFB
GMDN term: Surgical instrument maintenance lubricant

Device class: Class I
Regulation number: 872.4200
GUDID distribution status: In Commercial Distribution

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See all devices from Nakanishi Inc. →

Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)