WiScope® OTU-A

by Otu Medical Inc. 4 variants

WiScope® OTU-A (4201A0301T) is a Class II device made by Otu Medical Inc., cleared under FDA 510(k) K181977 on 14 Aug 2018 and listed in FDA GUDID since 17 Apr 2021 (UDI-DI 00850023925107), 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	Number00850023925107 UDI-DI	Date17 Apr 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK181977	Date14 Aug 2018Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00850023925107
FDA 510(k) database 510(k) number K181977

Across registries

2 registries list this device

FDA 510(k) K181977 decided 14 Aug 2018 Active
FDA GUDID UDI-DI 00850023925107 listed 17 Apr 2021 Listed

Timeline

2 dated events

14 Aug 2018 Cleared FDA 510(k) K181977
17 Apr 2021 Listed FDA GUDID 00850023925107

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: WiScope®
Generic name: Endoscopic video image processing unit
Model / Ref / Catalog: OTU-A, 4201A0301T

Primary DI / UDI-DI: 00850023925107
510(k) Number: K181977
FDA product code: FGB
GMDN term: Endoscopic video image processing unit

Device class: Class II
Regulation number: 876.1500
GUDID distribution status: In Commercial Distribution

Other devices from Otu Medical Inc.

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WiScope® OTU-T Pro

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WiScope® OTU-140S

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WiScope® OTU-110R

Class II

See all devices from Otu Medical Inc. →

Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)