Proctigard

FDA 510(k) K140558 · Access Pharmaceuticals, Inc.

Substantially Equivalent

510(k) numberK140558

Submission

Device name
Proctigard
Applicant
Access Pharmaceuticals, Inc.
New York, NY, US
Received
March 5, 2014
Decision date
July 16, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PHN – Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Device class
Unclassified

Mucoadhesive application for the protective coating of the rectal mucosa.

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K242634PuraStatPHN · Traditional 3-D Matrix Europe SAS01/15/2025SE
K213552PuraStat-RMPHN · Traditional 3-D Matrix, Inc.04/01/2022SE

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Questions and answers

When was Proctigard cleared by the FDA?

Proctigard (K140558) received a 510(k) decision of Substantially Equivalent on July 16, 2014, 133 days after the submission was received.

What is the product code of K140558?

The FDA product code is PHN – Protective Coating, Mucoadhesive Application, For The Rectal Mucosa, a Unclassified device.