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O'Regan Disposable Anoscope

by Canadian Theatre Products, Ltd.

510(k) K020702

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020702 Date29 Mar 2002ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FER
FDA applicant
Canadian Theatre Products , Ltd.
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The O'Regan Disposable Anoscope is an anoscope, a device used for medical examination. It is classified as a class 2 device. The device is used in the field of gastroenterology and urology.

The O'Regan Disposable Anoscope is supplied as a disposable device. It is regulated under the product code FER and has the regulation number 876.1500. The device has been cleared with a Traditional 510K clearance, with the decision code SESE, and has the k number K020702.