WiScope® OTU-A

by Otu Medical Inc. 4 variants

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850023925114 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 00850023925114
FDA 510(k) database 510(k) number K181977

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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Withdrawn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, 4201A0401T

Primary DI / UDI-DI: 00850023925114
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.

Aptra

Class IIa
WiScope® OTU-T Pro

Class II
WiScope® OTU-140S

Class II
WiScope® OTU-110R

Class II
WiScope® OTU-130S

Class II
WiScope® OTU-CK320S

Class II

See all devices from Otu Medical Inc. →

Properties

Prescription use
Serial number
Manufacturing date

Other properties (12)

Supplied sterile: No
Sterilise before use: No
Single use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Lot / batch number: No
Expiration date: No