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Sitzmarks

by Lafayette Pharmacal, Inc.

510(k) K881609

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 NumberK881609 Date8 Jul 1988ClearedStatusActive

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  • Withdrawn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
FFX
Device Class
Class II
Regulation
21 CFR Part 876.1725
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 Sitzmarks device is a System, Gastrointestinal Motility (Electrical), used in the field of Gastroenterology and Urology. It is classified as a class 2 device. The device has a product code of FFX and is regulated under regulation number 876.1725.

The Sitzmarks device is supplied by Lafayette Pharmacal, Inc. and has been authorized with an FDA 510K clearance, with the decision description being Substantially Equivalent. The device has a unique k number, K881609, and is associated with multiple fei numbers and registration numbers. The device is used in a medical setting and its storage and use are subject to standard medical device protocols.

Other devices from Lafayette Pharmacal, Inc.

Questions

AI-generated answers, 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.

  • What is the Sitzmarks device used for?

    The Sitzmarks device is used in the field of Gastroenterology and Urology to measure gastrointestinal motility.

  • Is the Sitzmarks device supplied sterile?

    The device data does not specify if the Sitzmarks device is supplied sterile, standard medical device protocols should be followed.

  • What is the regulatory classification of the Sitzmarks device?

    The Sitzmarks device is classified as a class 2 device, regulated under regulation number 876.1725.