PROCTIGARD— 510(k) K140558

Name: FDA 510(k) clearance K140558
Creator: U.S. Food and Drug Administration
Published: 2014-07-16

Substantially Equivalent

Access Pharmaceuticals, Inc.

FDA 510(k) clearance K140558 for PROCTIGARD, Substantially Equivalent on 2014-07-16. Applicant: Access Pharmaceuticals, Inc.. Device class: Unclassified.

Clearance details

Applicant: Access Pharmaceuticals, Inc.
Product code: Code PHN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2014-03-05
Decision date: 2014-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHN

view all

K261504 — PuraStat-RM2026-08-03
K253923 — PuraStat2026-01-07
K242634 — PuraStat2025-01-15
K213552 — PuraStat-RM2022-04-01

More clearances from Access Pharmaceuticals, Inc.

view all

K062795 — MUGARD MUCOADHESIVE ORAL WOUND RINSE2006-12-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.